KETOREX C SANWA— 510(k) K953452

Substantially Equivalent

Ihara Medics U.S., Inc.

FDA 510(k) clearance K953452 for KETOREX C SANWA, Substantially Equivalent on 1996-05-02. Applicant: Ihara Medics U.S., Inc.. Device class: 1.

Clearance details

Applicant: Ihara Medics U.S., Inc.
Product code: Code JMK
Device class: Class 1
Regulation: 21 CFR 862.1380
Advisory panel: Clinical Chemistry
Date received: 1995-07-18
Decision date: 1996-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMK

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K941427 — SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)1995-03-13
K862319 — HBDH (OPTIMIZED) REAGENT1986-07-07
K843774 — RAICHEM X-HBDH REAGENT1984-10-31

More clearances from Ihara Medics U.S., Inc.

K912373 — KETO-340 II1991-07-01
K903365 — KETOREX SANWA STANDARDS1990-12-20
K903366 — KETONE TEST B SANWA STANDARD1990-11-20
K903367 — KETONE TEST A SANWA STANDARD1990-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.