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FDA 510(k)

ULTRA CHEM CRESOLCAVERSACHEM #65082

K-Number: K830238 · 1983-02-18

ApplicantEmd Chemicals, Inc.
Decision Date1983-02-18
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA CHEM CRESOLCAVERSACHEM #65082 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830238. 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 ULTRA CHEM CRESOLCAVERSACHEM #65082?

ULTRA CHEM CRESOLCAVERSACHEM #65082 is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830238.

When did ULTRA CHEM CRESOLCAVERSACHEM #65082 receive FDA 510(k) clearance?

ULTRA CHEM CRESOLCAVERSACHEM #65082 received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830238.

Who is the listed applicant for ULTRA CHEM CRESOLCAVERSACHEM #65082?

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

What is the FDA product code for ULTRA CHEM CRESOLCAVERSACHEM #65082?

The FDA product code for ULTRA CHEM CRESOLCAVERSACHEM #65082 is CIC.

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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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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