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FDA 510(k)

DUPONT ACA STAR

K-Number: K941050 · 1994-11-10

ApplicantDupont Medical Products
Decision Date1994-11-10
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA STAR is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K941050. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT ACA STAR?

DUPONT ACA STAR is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Dupont Medical Products. The 510(k) number is K941050.

When did DUPONT ACA STAR receive FDA 510(k) clearance?

DUPONT ACA STAR received FDA 510(k) clearance on 1994-11-10, under 510(k) number K941050.

Who is the listed applicant for DUPONT ACA STAR?

The FDA 510(k) record lists Dupont Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPONT ACA STAR?

The FDA product code for DUPONT ACA STAR is JJQ.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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