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FDA 510(k)

TOTAL CALCIUM REAGENT SET

K-Number: K812835 · 1981-10-09

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-10-09
Product CodeCIC
Advisory CommitteeCH
DecisionUnknown

Device Summary

TOTAL CALCIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-10-09 under 510(k) number K812835. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TOTAL CALCIUM REAGENT SET?

TOTAL CALCIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-10-09. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812835.

When did TOTAL CALCIUM REAGENT SET receive FDA 510(k) clearance?

TOTAL CALCIUM REAGENT SET received FDA 510(k) clearance on 1981-10-09, under 510(k) number K812835.

Who is the listed applicant for TOTAL CALCIUM REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL CALCIUM REAGENT SET?

The FDA product code for TOTAL CALCIUM REAGENT SET is CIC.

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Other records listing Anco Medical Reagents & Assoc. as applicant

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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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