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FDA 510(k)

RH CONTROL

K-Number: K801425 · 1980-07-14

ApplicantNorth American Biologicals, Inc.
Decision Date1980-07-14
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RH CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is North American Biologicals, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801425. 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 CONTROL?

RH CONTROL is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is North American Biologicals, Inc.. The 510(k) number is K801425.

When did RH CONTROL receive FDA 510(k) clearance?

RH CONTROL received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801425.

Who is the listed applicant for RH CONTROL?

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

What is the FDA product code for RH CONTROL?

The FDA product code for RH CONTROL is KSF.

Related Clinical Trials

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.

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Other records listing North American 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.

K820301PLASMA POOLER HEAT SEALERK801219PLASMAPOOLERK781896BLOOD GROUP SUBSTANCE A,BK781895BLOOD GROUP SUBSTANCE BK781862BLOOD GROUP SUBSTANCE A

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 DadeK800658RST-SERIES CONTROLGamma Biologicals, Inc.K800310ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, 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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