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FDA 510(k)

BLOOD GROUP SUBSTANCE A,B

K-Number: K781896 · 1978-12-20

ApplicantNorth American Biologicals, Inc.
Decision Date1978-12-20
Product CodeKSX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLOOD GROUP SUBSTANCE A,B 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 1978-12-20 under 510(k) number K781896. The device is classified under product code KSX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GROUP SUBSTANCE A,B?

BLOOD GROUP SUBSTANCE A,B is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is North American Biologicals, Inc.. The 510(k) number is K781896.

When did BLOOD GROUP SUBSTANCE A,B receive FDA 510(k) clearance?

BLOOD GROUP SUBSTANCE A,B received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781896.

Who is the listed applicant for BLOOD GROUP SUBSTANCE A,B?

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 BLOOD GROUP SUBSTANCE A,B?

The FDA product code for BLOOD GROUP SUBSTANCE A,B is KSX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SEALERK801219PLASMAPOOLERK801425RH CONTROLK781895BLOOD GROUP SUBSTANCE BK781862BLOOD GROUP SUBSTANCE A

Related Devices (Code: KSX)

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.

K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K802534GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K800916P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.K781895BLOOD GROUP SUBSTANCE BNorth American Biologicals, Inc.K771488P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, 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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