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FDA 510(k)

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082

K-Number: K823756 · 1983-01-12

ApplicantEm Industries, Inc.
Decision Date1983-01-12
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 is the device name listed in this FDA 510(k) record. The listed applicant is Em Industries, Inc.. It received FDA 510(k) clearance on 1983-01-12 under 510(k) number K823756. 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 CRESOLPHTHALEIN CALCIUM 65082?

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 is a medical device that received FDA 510(k) clearance on 1983-01-12. The listed applicant is Em Industries, Inc.. The 510(k) number is K823756.

When did ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 receive FDA 510(k) clearance?

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 received FDA 510(k) clearance on 1983-01-12, under 510(k) number K823756.

Who is the listed applicant for ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082?

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

What is the FDA product code for ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082?

The FDA product code for ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 is CIC.

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Other records listing Em Industries, 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.

K832314CARDIZYME PLUS LD #65094/93

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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