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FDA 510(k)

P1 BLOOD GROUP SUBSTANCE

K-Number: K800916 · 1980-05-08

ApplicantTravenol Laboratories, S.A.
Decision Date1980-05-08
Product CodeKSX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

P1 BLOOD GROUP SUBSTANCE is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800916. 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 P1 BLOOD GROUP SUBSTANCE?

P1 BLOOD GROUP SUBSTANCE is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K800916.

When did P1 BLOOD GROUP SUBSTANCE receive FDA 510(k) clearance?

P1 BLOOD GROUP SUBSTANCE received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800916.

Who is the listed applicant for P1 BLOOD GROUP SUBSTANCE?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P1 BLOOD GROUP SUBSTANCE?

The FDA product code for P1 BLOOD GROUP SUBSTANCE is KSX.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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.

K802534GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.K781895BLOOD GROUP SUBSTANCE BNorth American Biologicals, Inc.K781896BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.K771488P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, 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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