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FDA 510(k)

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.

K-Number: K801662 · 1980-09-16

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-09-16
Product CodeDEP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801662. The device is classified under product code DEP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.?

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801662.

When did J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. receive FDA 510(k) clearance?

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801662.

Who is the listed applicant for J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.?

The FDA product code for J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. is DEP.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

View all 54 devices →

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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