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FDA 510(k)

CPK (UV) REAGENT KIT

K-Number: K855188 · 1986-03-05

ApplicantTechnostics Intl.
Decision Date1986-03-05
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK (UV) REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K855188. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK (UV) REAGENT KIT?

CPK (UV) REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Technostics Intl.. The 510(k) number is K855188.

When did CPK (UV) REAGENT KIT receive FDA 510(k) clearance?

CPK (UV) REAGENT KIT received FDA 510(k) clearance on 1986-03-05, under 510(k) number K855188.

Who is the listed applicant for CPK (UV) REAGENT KIT?

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

What is the FDA product code for CPK (UV) REAGENT KIT?

The FDA product code for CPK (UV) REAGENT KIT is JHS.

Related Clinical Trials

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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Other records listing Technostics Intl. 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.

K860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SETK855185GLUCOSE REAGENT SET

View all 21 devices →

Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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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