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FDA 510(k)

SYNERMED ISE REAGENTS

K-Number: K940194 · 1994-04-05

ApplicantSynermed, Inc.
Decision Date1994-04-05
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED ISE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1994-04-05 under 510(k) number K940194. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERMED ISE REAGENTS?

SYNERMED ISE REAGENTS is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Synermed, Inc.. The 510(k) number is K940194.

When did SYNERMED ISE REAGENTS receive FDA 510(k) clearance?

SYNERMED ISE REAGENTS received FDA 510(k) clearance on 1994-04-05, under 510(k) number K940194.

Who is the listed applicant for SYNERMED ISE REAGENTS?

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

What is the FDA product code for SYNERMED ISE REAGENTS?

The FDA product code for SYNERMED ISE REAGENTS is JGS.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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Related Devices (Code: JGS)

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.

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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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