HAEMOPHILUS TEST MEDIUM (AGAR)— 510(k) K892928
Substantially EquivalentRemel Co.
FDA 510(k) clearance K892928 for HAEMOPHILUS TEST MEDIUM (AGAR), Substantially Equivalent on 1989-06-13. Applicant: Remel Co.. Device class: 2.
Clearance details
- Applicant
- Remel Co.
- Product code
- Code JSO
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code JSO
view allMore clearances from Remel Co.
view allAdverse events under product code JSO
product code JSO- Malfunction
- 602
- Total
- 602
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K892928
K-number listed on FDA's recall record- Z-2038-2023 — Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
- Z-1424-2021 — Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
- Z-1425-2021 — Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K892928.
Data sourced from openFDA. This site is unofficial and independent of the FDA.