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FDA 510(k)

ACA IMMUNOGLOBIN M TEST PACK

K-Number: K812632 · 1981-09-29

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

Device Summary

ACA IMMUNOGLOBIN M TEST PACK 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 K812632. 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 ACA IMMUNOGLOBIN M TEST PACK?

ACA IMMUNOGLOBIN M TEST PACK 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 K812632.

When did ACA IMMUNOGLOBIN M TEST PACK receive FDA 510(k) clearance?

ACA IMMUNOGLOBIN M TEST PACK received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812632.

Who is the listed applicant for ACA IMMUNOGLOBIN M TEST PACK?

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 IMMUNOGLOBIN M TEST PACK?

The FDA product code for ACA IMMUNOGLOBIN M TEST PACK is DFT.

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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

View all 253 devices →

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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