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FDA 510(k)

RH-HR NEGATIVE CONTROL REAGENT

K-Number: K800239 · 1980-02-21

ApplicantGotham Biologics, Inc.
Decision Date1980-02-21
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RH-HR NEGATIVE CONTROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gotham Biologics, Inc.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K800239. The device is classified under product code KSF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RH-HR NEGATIVE CONTROL REAGENT?

RH-HR NEGATIVE CONTROL REAGENT is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Gotham Biologics, Inc.. The 510(k) number is K800239.

When did RH-HR NEGATIVE CONTROL REAGENT receive FDA 510(k) clearance?

RH-HR NEGATIVE CONTROL REAGENT received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800239.

Who is the listed applicant for RH-HR NEGATIVE CONTROL REAGENT?

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

What is the FDA product code for RH-HR NEGATIVE CONTROL REAGENT?

The FDA product code for RH-HR NEGATIVE CONTROL REAGENT is KSF.

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Other records listing Gotham Biologics, 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.

K800189BOVINE ALBUMIN 22% & 30% SOLUTIONS

Related Devices (Code: KSF)

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.

K811713AVI-D CONTROLOrtho Diagnostic Systems, Inc.K810599DADE RH CONTROL REAGENTAmerican DadeK801425RH CONTROLNorth American Biologicals, Inc.K800658RST-SERIES CONTROLGamma Biologicals, Inc.K800310ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.K790249TEST CELLSHyland Therapeutic Div., Travenol Laboratories

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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