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FDA 510(k)

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

K-Number: K874131 · 1987-12-04

ApplicantPointe Scientific, Inc.,
Decision Date1987-12-04
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CRESOLPHTHALEIN COMPLEXONE, CALCIUM is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1987-12-04 under 510(k) number K874131. 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 CRESOLPHTHALEIN COMPLEXONE, CALCIUM?

CRESOLPHTHALEIN COMPLEXONE, CALCIUM is a medical device that received FDA 510(k) clearance on 1987-12-04. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K874131.

When did CRESOLPHTHALEIN COMPLEXONE, CALCIUM receive FDA 510(k) clearance?

CRESOLPHTHALEIN COMPLEXONE, CALCIUM received FDA 510(k) clearance on 1987-12-04, under 510(k) number K874131.

Who is the listed applicant for CRESOLPHTHALEIN COMPLEXONE, CALCIUM?

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

What is the FDA product code for CRESOLPHTHALEIN COMPLEXONE, CALCIUM?

The FDA product code for CRESOLPHTHALEIN COMPLEXONE, CALCIUM is CIC.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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