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FDA 510(k)

AUTOMATED IMMUNOPRECIPITIN METHOD/IGA

K-Number: K803274 · 1981-01-26

ApplicantIcl Scientific
Decision Date1981-01-26
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOMATED IMMUNOPRECIPITIN METHOD/IGA is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K803274. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED IMMUNOPRECIPITIN METHOD/IGA?

AUTOMATED IMMUNOPRECIPITIN METHOD/IGA is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Icl Scientific. The 510(k) number is K803274.

When did AUTOMATED IMMUNOPRECIPITIN METHOD/IGA receive FDA 510(k) clearance?

AUTOMATED IMMUNOPRECIPITIN METHOD/IGA received FDA 510(k) clearance on 1981-01-26, under 510(k) number K803274.

Who is the listed applicant for AUTOMATED IMMUNOPRECIPITIN METHOD/IGA?

The FDA 510(k) record lists Icl Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED IMMUNOPRECIPITIN METHOD/IGA?

The FDA product code for AUTOMATED IMMUNOPRECIPITIN METHOD/IGA is CZP.

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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