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FDA 510(k)

GIBCO MYCOTECT 189-5670

K-Number: K851275 · 1985-06-21

ApplicantGibco Laboratories Life Technologies, Inc.
Decision Date1985-06-21
Product CodeKIW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GIBCO MYCOTECT 189-5670 is the device name listed in this FDA 510(k) record. The listed applicant is Gibco Laboratories Life Technologies, Inc.. It received FDA 510(k) clearance on 1985-06-21 under 510(k) number K851275. The device is classified under product code KIW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIBCO MYCOTECT 189-5670?

GIBCO MYCOTECT 189-5670 is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Gibco Laboratories Life Technologies, Inc.. The 510(k) number is K851275.

When did GIBCO MYCOTECT 189-5670 receive FDA 510(k) clearance?

GIBCO MYCOTECT 189-5670 received FDA 510(k) clearance on 1985-06-21, under 510(k) number K851275.

Who is the listed applicant for GIBCO MYCOTECT 189-5670?

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

What is the FDA product code for GIBCO MYCOTECT 189-5670?

The FDA product code for GIBCO MYCOTECT 189-5670 is KIW.

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Other records listing Gibco Laboratories Life Technologies, 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.

K871855SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORMK871541MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226K870134MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PREK864755PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORMK864014LOMBARD DOWELL AGAR BASEK863821MUELLER HINTON AGAR W/4%NACL AND OXACILLIN

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Related Devices (Code: KIW)

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.

K860695GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)Gibco Laboratories Life Technologies, 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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