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FDA 510(k)

J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA

K-Number: K801282 · 1980-06-30

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-06-30
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA 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 1980-06-30 under 510(k) number K801282. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA?

J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801282.

When did J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA receive FDA 510(k) clearance?

J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801282.

Who is the listed applicant for J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA?

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 IMMUNO. M. NEPHELOMETRIC ASSA?

The FDA product code for J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA is DFT.

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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

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Related Devices (Code: DFT)

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.

K983132IGMAbbott LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, 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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