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FDA 510(k)

SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH

K-Number: K851250 · 1985-04-22

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-04-22
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-04-22 under 510(k) number K851250. 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 TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH?

SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K851250.

When did SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH receive FDA 510(k) clearance?

SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH received FDA 510(k) clearance on 1985-04-22, under 510(k) number K851250.

Who is the listed applicant for SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH?

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

What is the FDA product code for SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH?

The FDA product code for SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH is JSG.

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Other records listing Roche Diagnostic Systems, 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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