KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS— 510(k) K861022
Substantially EquivalentMicro-Bio-Logics
FDA 510(k) clearance K861022 for KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS, Substantially Equivalent on 1986-04-04. Applicant: Micro-Bio-Logics. Device class: 1.
Clearance details
- Applicant
- Micro-Bio-Logics
- Product code
- Code JTR
- Device class
- Class 1
- Regulation
- 21 CFR 866.2480
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Cloud, MN, US
Recent devices under product code JTR
view allMore clearances from Micro-Bio-Logics
view allRecalls naming K861022
K-number listed on FDA's recall record- Z-0984-2026 — KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- Z-0985-2026 — KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
- Z-0986-2026 — LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
- Z-2194-2025 — LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
- Z-2124-2025 — KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Z-1957-2025 — KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
- Z-1483-2024 — KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
- Z-0307-2024 — KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
- Z-0308-2024 — LYFO-DISK, P. venetum, Catalog number 0794L
- Z-2576-2023 — KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
- Z-1125-2022 — KWIK-STIK" plus: Clostridium perfringens
- Z-0543-2022 — KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
- Z-0544-2022 — KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
- Z-0511-2022 — KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
- Z-0546-2022 — KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
- Z-0302-2021 — Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
- Z-0303-2021 — Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
- Z-0304-2021 — Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
- Z-0402-2021 — Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.
- Z-0581-2022 — KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K861022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.