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FDA 510(k)

CAMPY THIOGLYCOLLATE (TUBE)

K-Number: K812451 · 1981-09-23

ApplicantGranite Diagnostics, Inc.
Decision Date1981-09-23
Product CodeJSD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAMPY THIOGLYCOLLATE (TUBE) is the device name listed in this FDA 510(k) record. The listed applicant is Granite Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812451. The device is classified under product code JSD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMPY THIOGLYCOLLATE (TUBE)?

CAMPY THIOGLYCOLLATE (TUBE) is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K812451.

When did CAMPY THIOGLYCOLLATE (TUBE) receive FDA 510(k) clearance?

CAMPY THIOGLYCOLLATE (TUBE) received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812451.

Who is the listed applicant for CAMPY THIOGLYCOLLATE (TUBE)?

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

What is the FDA product code for CAMPY THIOGLYCOLLATE (TUBE)?

The FDA product code for CAMPY THIOGLYCOLLATE (TUBE) is JSD.

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Other records listing Granite Diagnostics, 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.

K850969INHIBITORY MOLD AGAR PLATEK850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAK833254STREPTOCOCCUS ID TRIPLATE SYSTEMK832365TCBS AGARK831349STREPTOCOCUS ID PLATEK830252DIPCHEX DIP-SLIDE CULTURE SYS

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Related Devices (Code: JSD)

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.

K883075FASTIDIOUS INOCULUM BROTHBaxter Healthcare CorpK880107CAMPY BROTHHardy MediaK873324SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331Lakewood Biochemical Co., Inc.K873218BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802Lakewood Biochemical Co., Inc.K871447TODD HEWITT W/CNA (LIM BROTH)Remel Co.K871640ALKALINE PEPTONE WATERBd Becton Dickinson Vacutainer Systems Preanalytic

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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