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FDA 510(k)

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ

K-Number: K853050 · 1985-08-02

ApplicantSimmler, Inc.
Decision Date1985-08-02
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K853050. 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 REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ?

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is Simmler, Inc.. The 510(k) number is K853050.

When did CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ receive FDA 510(k) clearance?

CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ received FDA 510(k) clearance on 1985-08-02, under 510(k) number K853050.

Who is the listed applicant for CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ?

The FDA 510(k) record lists Simmler, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ?

The FDA product code for CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ is CIC.

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Other records listing Simmler, Inc. 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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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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