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FDA 510(k)

EMIT ANCILLARY REAGENTS

K-Number: K844947 · 1985-06-28

ApplicantSyva Co.
Decision Date1985-06-28
Product CodeKIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT ANCILLARY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K844947. The device is classified under product code KIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT ANCILLARY REAGENTS?

EMIT ANCILLARY REAGENTS is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Syva Co.. The 510(k) number is K844947.

When did EMIT ANCILLARY REAGENTS receive FDA 510(k) clearance?

EMIT ANCILLARY REAGENTS received FDA 510(k) clearance on 1985-06-28, under 510(k) number K844947.

Who is the listed applicant for EMIT ANCILLARY REAGENTS?

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

What is the FDA product code for EMIT ANCILLARY REAGENTS?

The FDA product code for EMIT ANCILLARY REAGENTS is KIE.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: KIE)

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.

K964588WATERS 515 HPLC PUMP (515)Waters CorporationK935666PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMPThe Perkin-Elmer Corp.K924347WATERS(TM) 996 PDAMillipore Corp.K914841CHROMATOGRAPHY CLINICAL USE 75JQRMillipore Corp.K911299EQUIPMENT/MATERIAL DECONTAMINATING KITRohm and Haas Co.K862506THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTORMillipore Corp.

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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