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FDA 510(k)

DRI-STAT ENZYMATIC BILIRUBIN TEST KIT

K-Number: K843174 · 1984-09-14

ApplicantBeckman Instruments, Inc.
Decision Date1984-09-14
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DRI-STAT ENZYMATIC BILIRUBIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K843174. The device is classified under product code JFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI-STAT ENZYMATIC BILIRUBIN TEST KIT?

DRI-STAT ENZYMATIC BILIRUBIN TEST KIT is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K843174.

When did DRI-STAT ENZYMATIC BILIRUBIN TEST KIT receive FDA 510(k) clearance?

DRI-STAT ENZYMATIC BILIRUBIN TEST KIT received FDA 510(k) clearance on 1984-09-14, under 510(k) number K843174.

Who is the listed applicant for DRI-STAT ENZYMATIC BILIRUBIN TEST KIT?

The FDA 510(k) record lists Beckman Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI-STAT ENZYMATIC BILIRUBIN TEST KIT?

The FDA product code for DRI-STAT ENZYMATIC BILIRUBIN TEST KIT is JFM.

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Related Devices (Code: JFM)

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.

K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.K152343Direct BilirubinRandox Laboratories LimitedK152344Total BilirubinRandox Laboratories LimitedK063845ADVIA CHEMISTRY TOTAL BILIRUBIN_2Bayer Healthcare, LLCK053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791Wako Chemicals USA, Inc.K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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