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FDA 510(k)

CALCIUM, CATALOGUE NUMBER 122-20

K-Number: K881054 · 1988-04-18

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-04-18
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM, CATALOGUE NUMBER 122-20 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 1988-04-18 under 510(k) number K881054. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM, CATALOGUE NUMBER 122-20?

CALCIUM, CATALOGUE NUMBER 122-20 is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K881054.

When did CALCIUM, CATALOGUE NUMBER 122-20 receive FDA 510(k) clearance?

CALCIUM, CATALOGUE NUMBER 122-20 received FDA 510(k) clearance on 1988-04-18, under 510(k) number K881054.

Who is the listed applicant for CALCIUM, CATALOGUE NUMBER 122-20?

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 NUMBER 122-20?

The FDA product code for CALCIUM, CATALOGUE NUMBER 122-20 is CIC.

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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: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, 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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