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FDA 510(k)

ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14

K-Number: K904660 · 1990-11-20

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1990-11-20
Product CodeJFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904660. 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 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14?

ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K904660.

When did ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 receive FDA 510(k) clearance?

ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904660.

Who is the listed applicant for ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14?

The FDA product code for ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 is JFM.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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

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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