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FDA 510(k)

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409

K-Number: K905659 · 1991-01-15

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-01-15
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K905659. 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 SYSTEMATE CALCIUM (EPOS APPLICATION) #65409?

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K905659.

When did SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 receive FDA 510(k) clearance?

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 received FDA 510(k) clearance on 1991-01-15, under 510(k) number K905659.

Who is the listed applicant for SYSTEMATE CALCIUM (EPOS APPLICATION) #65409?

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

What is the FDA product code for SYSTEMATE CALCIUM (EPOS APPLICATION) #65409?

The FDA product code for SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 is CIC.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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