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FDA 510(k)

DC-LIP, CATALOGUE NUMBER SE-020

K-Number: K852594 · 1985-07-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1985-07-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DC-LIP, CATALOGUE NUMBER SE-020 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 1985-07-12 under 510(k) number K852594. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-LIP, CATALOGUE NUMBER SE-020?

DC-LIP, CATALOGUE NUMBER SE-020 is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K852594.

When did DC-LIP, CATALOGUE NUMBER SE-020 receive FDA 510(k) clearance?

DC-LIP, CATALOGUE NUMBER SE-020 received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852594.

Who is the listed applicant for DC-LIP, CATALOGUE NUMBER SE-020?

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 DC-LIP, CATALOGUE NUMBER SE-020?

The FDA product code for DC-LIP, CATALOGUE NUMBER SE-020 is JJY.

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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: JJY)

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.

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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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