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FDA 510(k)

PENTEX BOVINE ALBUMIN 30% SOLUTION

K-Number: K800943 · 1980-05-08

ApplicantMiles Laboratories, Inc.
Decision Date1980-05-08
Product CodeKSG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PENTEX BOVINE ALBUMIN 30% SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800943. The device is classified under product code KSG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTEX BOVINE ALBUMIN 30% SOLUTION?

PENTEX BOVINE ALBUMIN 30% SOLUTION is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K800943.

When did PENTEX BOVINE ALBUMIN 30% SOLUTION receive FDA 510(k) clearance?

PENTEX BOVINE ALBUMIN 30% SOLUTION received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800943.

Who is the listed applicant for PENTEX BOVINE ALBUMIN 30% SOLUTION?

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

What is the FDA product code for PENTEX BOVINE ALBUMIN 30% SOLUTION?

The FDA product code for PENTEX BOVINE ALBUMIN 30% SOLUTION is KSG.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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Related Devices (Code: KSG)

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.

K812565ELUTION SOLUTIONBiological Corp. of AmericaK812222EM-XBiological Corp. of AmericaK800189BOVINE ALBUMIN 22% & 30% SOLUTIONSGotham Biologics, Inc.K791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONOrtho Diagnostics, Inc.K791113LOW IONIC STRENGTH SOLUTION (LISS)Hyland Therapeutic Div., Travenol LaboratoriesK790973LO-IONGamma Biologicals, 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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