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FDA 510(k)

ANAIROBE-TEK

K-Number: K802626 · 1980-11-12

ApplicantFlow Laboratories, Inc.
Decision Date1980-11-12
Product CodeJSP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANAIROBE-TEK is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802626. The device is classified under product code JSP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAIROBE-TEK?

ANAIROBE-TEK is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K802626.

When did ANAIROBE-TEK receive FDA 510(k) clearance?

ANAIROBE-TEK received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802626.

Who is the listed applicant for ANAIROBE-TEK?

The FDA 510(k) record lists Flow Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANAIROBE-TEK?

The FDA product code for ANAIROBE-TEK is JSP.

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Other records listing Flow Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K861897UNISKAN IIK862066TITERTEK MICROPLATE WASHER S-12K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEK860762GAMMA-FREE HORSE SERUM

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Related Devices (Code: JSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945488LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945489LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945487LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K944528BBLCRYSTAL ANAEROBE ID SYSTEMBecton Dickinson Microbiology SystemsK910666VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATIONVitek Systems, Inc.K900996VITEK ANAEROBE IDENTIFICATION CARDVitek Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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