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FDA 510(k)

ANALYST ANALYTICAL TEST ROTORS

K-Number: K862274 · 1986-07-29

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1986-07-29
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYST ANALYTICAL TEST ROTORS is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1986-07-29 under 510(k) number K862274. 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 ANALYST ANALYTICAL TEST ROTORS?

ANALYST ANALYTICAL TEST ROTORS is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K862274.

When did ANALYST ANALYTICAL TEST ROTORS receive FDA 510(k) clearance?

ANALYST ANALYTICAL TEST ROTORS received FDA 510(k) clearance on 1986-07-29, under 510(k) number K862274.

Who is the listed applicant for ANALYST ANALYTICAL TEST ROTORS?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANALYST ANALYTICAL TEST ROTORS?

The FDA product code for ANALYST ANALYTICAL TEST ROTORS is CIC.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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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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