BIO SPEC GRAMAFLUOR TEST KIT— 510(k) K860091

Substantially Equivalent

Bio Spec, Inc.

FDA 510(k) clearance K860091 for BIO SPEC GRAMAFLUOR TEST KIT, Substantially Equivalent on 1986-01-21. Applicant: Bio Spec, Inc.. Device class: 1.

Clearance details

Applicant: Bio Spec, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1986-01-10
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bio Spec, Inc.

K860041 — STREP D FLUOR1986-01-24
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Data sourced from openFDA. This site is unofficial and independent of the FDA.