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FDA 510(k)

ENZYMATIC ACETAMINOPHEN ASSAY

K-Number: K841930 · 1984-06-25

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-06-25
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC ACETAMINOPHEN ASSAY 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 1984-06-25 under 510(k) number K841930. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMATIC ACETAMINOPHEN ASSAY?

ENZYMATIC ACETAMINOPHEN ASSAY is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K841930.

When did ENZYMATIC ACETAMINOPHEN ASSAY receive FDA 510(k) clearance?

ENZYMATIC ACETAMINOPHEN ASSAY received FDA 510(k) clearance on 1984-06-25, under 510(k) number K841930.

Who is the listed applicant for ENZYMATIC ACETAMINOPHEN ASSAY?

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 ACETAMINOPHEN ASSAY?

The FDA product code for ENZYMATIC ACETAMINOPHEN ASSAY is LKP.

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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: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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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