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FDA 510(k)

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

K-Number: K882586 · 1988-08-08

ApplicantA-Kem, Inc.
Decision Date1988-08-08
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882586. 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 A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM?

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is A-Kem, Inc.. The 510(k) number is K882586.

When did A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM receive FDA 510(k) clearance?

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882586.

Who is the listed applicant for A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM?

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

What is the FDA product code for A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM?

The FDA product code for A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM is CIC.

Related Clinical Trials

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Other records listing A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK873132BUN REAGENT KIT

View all 13 devices →

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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