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FDA 510(k)

SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE

K-Number: K812732 · 1981-10-19

ApplicantHoffmann-La Roche, Inc.
Decision Date1981-10-19
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812732. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE?

SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K812732.

When did SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE receive FDA 510(k) clearance?

SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812732.

Who is the listed applicant for SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE?

The FDA product code for SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE is JSG.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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Related Devices (Code: JSG)

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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.K881557TRYPTONEAcumedia Manufacturers, Inc.K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.K881533BLOOD AGAR BASE NO. 2Acumedia Manufacturers, 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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