PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS— 510(k) K850333

Name: FDA 510(k) clearance K850333
Creator: U.S. Food and Drug Administration
Published: 1985-02-27

Substantially Equivalent

Shaban Mfg. Co.

FDA 510(k) clearance K850333 for PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS, Substantially Equivalent on 1985-02-27. Applicant: Shaban Mfg. Co.. Device class: 1.

Clearance details

Applicant: Shaban Mfg. Co.
Product code: Code KPA
Device class: Class 1
Regulation: 21 CFR 864.3800
Advisory panel: Pathology
Date received: 1985-01-28
Decision date: 1985-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPA

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K933996 — PROFIBLOT1994-01-28
K884258 — VERSABLOT1988-12-14
K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER1988-05-13
K880745 — LX-100 SLIDE STAINER1988-04-27
K874887 — WESBLOT PROCESSOR1988-03-24

More clearances from Shaban Mfg. Co.

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K853621 — REPLACEMENT PUMP TUBING1985-12-05
K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS1985-02-27
K844781 — MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB1985-02-01
K844235 — CHLORIDE STANDARD1984-11-20
K842656 — REPLACEMENT PARTS NOVA ELECTROLYTE ANAL1984-08-12

Adverse events under product code KPA

product code KPA

Malfunction: 1,177
Total: 1,177

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.