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FDA 510(k)

CALCIUM, CATALOGUE NUMBER140-20

K-Number: K895873 · 1989-12-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1989-12-12
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM, CATALOGUE NUMBER140-20 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 1989-12-12 under 510(k) number K895873. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM, CATALOGUE NUMBER140-20?

CALCIUM, CATALOGUE NUMBER140-20 is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K895873.

When did CALCIUM, CATALOGUE NUMBER140-20 receive FDA 510(k) clearance?

CALCIUM, CATALOGUE NUMBER140-20 received FDA 510(k) clearance on 1989-12-12, under 510(k) number K895873.

Who is the listed applicant for CALCIUM, CATALOGUE NUMBER140-20?

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 CALCIUM, CATALOGUE NUMBER140-20?

The FDA product code for CALCIUM, CATALOGUE NUMBER140-20 is CJY.

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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: CJY)

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.

K244042Calcium2Abbott IrelandK191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SASK182042Randox Calcium (Ca)Randox Laboratories, Ltd.K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SASK120626EON CALCIUM REGENTVital Diagnostics (Manufacturing) PtyltdK083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics

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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