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FDA 510(k)

CALCIUM DYE REAGENT-CS-718-A/BUFFER

K-Number: K833035 · 1983-11-03

ApplicantFisher Scientific Co., LLC
Decision Date1983-11-03
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM DYE REAGENT-CS-718-A/BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833035. 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 CALCIUM DYE REAGENT-CS-718-A/BUFFER?

CALCIUM DYE REAGENT-CS-718-A/BUFFER is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K833035.

When did CALCIUM DYE REAGENT-CS-718-A/BUFFER receive FDA 510(k) clearance?

CALCIUM DYE REAGENT-CS-718-A/BUFFER received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833035.

Who is the listed applicant for CALCIUM DYE REAGENT-CS-718-A/BUFFER?

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

What is the FDA product code for CALCIUM DYE REAGENT-CS-718-A/BUFFER?

The FDA product code for CALCIUM DYE REAGENT-CS-718-A/BUFFER is CIC.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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