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FDA 510(k)

RECAP

K-Number: K780665 · 1978-06-06

ApplicantBca Biological Corp. of America
Decision Date1978-06-06
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RECAP is the device name listed in this FDA 510(k) record. The listed applicant is Bca Biological Corp. of America. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780665. 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 RECAP?

RECAP is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Bca Biological Corp. of America. The 510(k) number is K780665.

When did RECAP receive FDA 510(k) clearance?

RECAP received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780665.

Who is the listed applicant for RECAP?

The FDA 510(k) record lists Bca Biological Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECAP?

The FDA product code for RECAP 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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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.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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