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FDA 510(k)

ACA IMMUNOGLOBULIN A/M CALIBRATORS

K-Number: K812633 · 1981-09-29

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1981-09-29
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACA IMMUNOGLOBULIN A/M CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812633. 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 ACA IMMUNOGLOBULIN A/M CALIBRATORS?

ACA IMMUNOGLOBULIN A/M CALIBRATORS is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K812633.

When did ACA IMMUNOGLOBULIN A/M CALIBRATORS receive FDA 510(k) clearance?

ACA IMMUNOGLOBULIN A/M CALIBRATORS received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812633.

Who is the listed applicant for ACA IMMUNOGLOBULIN A/M CALIBRATORS?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA IMMUNOGLOBULIN A/M CALIBRATORS?

The FDA product code for ACA IMMUNOGLOBULIN A/M CALIBRATORS is CZP.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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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