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FDA 510(k)

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS

K-Number: K832708 · 1983-10-14

ApplicantAmerican Dade
Decision Date1983-10-14
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832708. 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 PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS?

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is American Dade. The 510(k) number is K832708.

When did PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS receive FDA 510(k) clearance?

PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832708.

Who is the listed applicant for PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS?

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

What is the FDA product code for PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS?

The FDA product code for PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS is CIC.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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