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FDA 510(k)

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD

K-Number: K921455 · 1992-04-29

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1992-04-29
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD 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 1992-04-29 under 510(k) number K921455. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD?

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K921455.

When did ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD receive FDA 510(k) clearance?

ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD received FDA 510(k) clearance on 1992-04-29, under 510(k) number K921455.

Who is the listed applicant for ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD?

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 LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD?

The FDA product code for ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD is CFE.

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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: CFE)

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.

K100307GELSCAN, MODEL 1206SebiaK022455SPIFE LD-12 KIT, MODEL 3338Helena LaboratoriesK020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452Helena LaboratoriesK970477HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebiaK940224CARDIO REP LDHelena LaboratoriesK905861ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METHE.I. Dupont DE Nemours & Co., 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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