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FDA 510(k)

TEST, REFORMULATED HYCEL HMA CALCIUM

K-Number: K760468 · 1976-11-01

ApplicantHycel, Inc.
Decision Date1976-11-01
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST, REFORMULATED HYCEL HMA CALCIUM is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760468. 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 TEST, REFORMULATED HYCEL HMA CALCIUM?

TEST, REFORMULATED HYCEL HMA CALCIUM is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Hycel, Inc.. The 510(k) number is K760468.

When did TEST, REFORMULATED HYCEL HMA CALCIUM receive FDA 510(k) clearance?

TEST, REFORMULATED HYCEL HMA CALCIUM received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760468.

Who is the listed applicant for TEST, REFORMULATED HYCEL HMA CALCIUM?

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

What is the FDA product code for TEST, REFORMULATED HYCEL HMA CALCIUM?

The FDA product code for TEST, REFORMULATED HYCEL HMA CALCIUM is CIC.

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Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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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