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FDA 510(k)

CLINISTAT TRIGLYCERIDES REAGENT TEST

K-Number: K885134 · 1989-02-10

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-02-10
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT TRIGLYCERIDES REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K885134. The device is classified under product code JGY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINISTAT TRIGLYCERIDES REAGENT TEST?

CLINISTAT TRIGLYCERIDES REAGENT TEST is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K885134.

When did CLINISTAT TRIGLYCERIDES REAGENT TEST receive FDA 510(k) clearance?

CLINISTAT TRIGLYCERIDES REAGENT TEST received FDA 510(k) clearance on 1989-02-10, under 510(k) number K885134.

Who is the listed applicant for CLINISTAT TRIGLYCERIDES REAGENT TEST?

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

What is the FDA product code for CLINISTAT TRIGLYCERIDES REAGENT TEST?

The FDA product code for CLINISTAT TRIGLYCERIDES REAGENT TEST is JGY.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: JGY)

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.

K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K971005TRIGLYCERIDESDerma Media Lab., Inc.K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, 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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