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FDA 510(k)

SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER

K-Number: K880949 · 1988-04-05

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1988-04-05
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880949. 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 SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER?

SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K880949.

When did SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER receive FDA 510(k) clearance?

SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880949.

Who is the listed applicant for SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER?

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

What is the FDA product code for SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER?

The FDA product code for SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER is CJY.

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Other records listing Advanced Biomedical Methods, 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.

K945353CLARIT(TM)K864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852783SGOT/ALT REAGENTK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZERK850380INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER

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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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