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FDA 510(k)

THEOPHYLLINE TEST PACK ACA

K-Number: K831934 · 1983-09-12

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1983-09-12
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE TEST PACK ACA 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 1983-09-12 under 510(k) number K831934. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE TEST PACK ACA?

THEOPHYLLINE TEST PACK ACA is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K831934.

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

THEOPHYLLINE TEST PACK ACA received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831934.

Who is the listed applicant for THEOPHYLLINE TEST PACK ACA?

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 THEOPHYLLINE TEST PACK ACA?

The FDA product code for THEOPHYLLINE TEST PACK ACA is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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