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FDA 510(k)

ACA LIPASE ANALYTICAL TEST PACK

K-Number: K770364 · 1977-04-15

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1977-04-15
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA LIPASE ANALYTICAL 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 1977-04-15 under 510(k) number K770364. The device is classified under product code CET. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA LIPASE ANALYTICAL TEST PACK?

ACA LIPASE ANALYTICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1977-04-15. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K770364.

When did ACA LIPASE ANALYTICAL TEST PACK receive FDA 510(k) clearance?

ACA LIPASE ANALYTICAL TEST PACK received FDA 510(k) clearance on 1977-04-15, under 510(k) number K770364.

Who is the listed applicant for ACA LIPASE ANALYTICAL 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 LIPASE ANALYTICAL TEST PACK?

The FDA product code for ACA LIPASE ANALYTICAL TEST PACK is CET.

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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: CET)

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.

K970124LIPASE REAGENT SET (COLIPASE METHOD)Teco DiagnosticsK940457LIPASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.K915706LIPASE REAGENT SETTech Intl. Co.K901858MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TESTE.I. Dupont DE Nemours & Co., Inc.K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.K885078LIPASE SR LIQUID STABLE REAGENT SETMedical Analysis Systems, 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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