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FDA 510(k)

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD

K-Number: K950180 · 1995-03-15

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1995-03-15
Product CodeDLI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE 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 1995-03-15 under 510(k) number K950180. The device is classified under product code DLI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD?

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K950180.

When did DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD receive FDA 510(k) clearance?

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD received FDA 510(k) clearance on 1995-03-15, under 510(k) number K950180.

Who is the listed applicant for DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE 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 DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD?

The FDA product code for DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD is DLI.

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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: DLI)

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.

K930208CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICOHeraeus Kulzer, Inc.K860350SERUM CHOLINESTERASE REAGENT SETSterling Diagnostics, Inc.K860641EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93Em Diagnostic Systems, Inc.K833062SERUM CHOLINESTERASE REAGENT SETSterling Biochemical, Inc.K771024CHOLINESTERASE REAGENT SYSTEMAmerican Monitor Corp.

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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