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FDA 510(k)

BACTO-HATTS

K-Number: K791897 · 1979-11-13

ApplicantDifco Laboratories, Inc.
Decision Date1979-11-13
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTO-HATTS is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K791897. The device is classified under product code GMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTO-HATTS?

BACTO-HATTS is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K791897.

When did BACTO-HATTS receive FDA 510(k) clearance?

BACTO-HATTS received FDA 510(k) clearance on 1979-11-13, under 510(k) number K791897.

Who is the listed applicant for BACTO-HATTS?

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

What is the FDA product code for BACTO-HATTS?

The FDA product code for BACTO-HATTS is GMT.

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Other records listing Difco 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.

K971211DISPENS-O-DISC SPARFLOXACINK971120DISPENS-O-DISC (TM) LEVOFLOXACINK963508DISPENS-O-DISC MEROPENEMK961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)K954783DRYSLIDE CARTARRHALISK954784DRYSIDE NEISSERIA

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Related Devices (Code: GMT)

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.

K971502SERODIA TP-PAScimedx Tekfile ServicesK911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K911266MODIFIED PK TP CONTROLOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K896410CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.K893124OLYMPUS PK(TM) TPFujirebio Diagnostics,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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