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FDA 510(k)

SERUM CALCIUM REAGENT SET

K-Number: K841051 · 1984-05-01

ApplicantMedical Specialties, Inc.
Decision Date1984-05-01
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM CALCIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841051. 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 SERUM CALCIUM REAGENT SET?

SERUM CALCIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841051.

When did SERUM CALCIUM REAGENT SET receive FDA 510(k) clearance?

SERUM CALCIUM REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841051.

Who is the listed applicant for SERUM CALCIUM REAGENT SET?

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

What is the FDA product code for SERUM CALCIUM REAGENT SET?

The FDA product code for SERUM CALCIUM REAGENT SET is CIC.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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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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