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FDA 510(k)

COLUMBIA V AGAR W/5% HUMAN BLOOD

K-Number: K823311 · 1982-12-15

ApplicantTroy Biologicals, Inc.
Decision Date1982-12-15
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLUMBIA V AGAR W/5% HUMAN BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Troy Biologicals, Inc.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823311. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLUMBIA V AGAR W/5% HUMAN BLOOD?

COLUMBIA V AGAR W/5% HUMAN BLOOD is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Troy Biologicals, Inc.. The 510(k) number is K823311.

When did COLUMBIA V AGAR W/5% HUMAN BLOOD receive FDA 510(k) clearance?

COLUMBIA V AGAR W/5% HUMAN BLOOD received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823311.

Who is the listed applicant for COLUMBIA V AGAR W/5% HUMAN BLOOD?

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

What is the FDA product code for COLUMBIA V AGAR W/5% HUMAN BLOOD?

The FDA product code for COLUMBIA V AGAR W/5% HUMAN BLOOD is JSH.

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Other records listing Troy Biologicals, 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.

K861301BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000K832860SXT BLOOD AGARK832863STREP ID QUADK832861SABOURAUD DEXTROSE AGARK832862TRANSGROW MEDIUMK823306HEMOPHILUS QUAD 10 PLATE

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Related Devices (Code: JSH)

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.

K881551PHENOL RED BROTH BASEAcumedia Manufacturers, Inc.K881553RUSSELL DOUBLE SUGAR AGARAcumedia Manufacturers, Inc.K881486DNASE TEST AGARAcumedia Manufacturers, Inc.K881540FLO AGARAcumedia Manufacturers, Inc.K881559UREA AGAR BASEAcumedia Manufacturers, Inc.K881560UREA BROTHAcumedia 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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