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FDA 510(k)

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086

K-Number: K780461 · 1978-04-12

ApplicantSyva Co.
Decision Date1978-04-12
Product CodeDLF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1978-04-12 under 510(k) number K780461. The device is classified under product code DLF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYZER-SUPPLEMENT, KINETIC, LKB 2086?

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 is a medical device that received FDA 510(k) clearance on 1978-04-12. The listed applicant is Syva Co.. The 510(k) number is K780461.

When did ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 receive FDA 510(k) clearance?

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 received FDA 510(k) clearance on 1978-04-12, under 510(k) number K780461.

Who is the listed applicant for ANALYZER-SUPPLEMENT, KINETIC, LKB 2086?

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 ANALYZER-SUPPLEMENT, KINETIC, LKB 2086?

The FDA product code for ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 is DLF.

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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: DLF)

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.

K881607EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.K850174TDX ETHOSUXIMIDEAbbott LaboratoriesK844204EMIT QST ETHOSUXIMIDE ASSAYSyva Co.K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.K823801AMES TDA ETHOSUXIMIDE TESTMiles Laboratories, Inc.K823745ADVANCE EMIT-AED ETHOSUXIMIDESyva Co.

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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