STAPHYLASE TEST— 510(k) K874303

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K874303 for STAPHYLASE TEST, Substantially Equivalent on 1987-11-06. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code LHT
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1987-10-20
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHT

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K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT1982-04-14
K820347 — ACCU-STAPH1982-03-04
K812434 — DIAGNOSTIC KITS & KIT COMPONENTS1981-09-23

More clearances from Oxoid U.S.A., Inc.

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K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10
K872135 — MCBRIDE MEDIUM CM 8191987-06-15

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