GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*— 510(k) K772033

Substantially Equivalent

Harleco

FDA 510(k) clearance K772033 for GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*, Substantially Equivalent on 1977-11-17. Applicant: Harleco. Device class: 1.

Clearance details

Applicant: Harleco
Product code: Code JMK
Device class: Class 1
Regulation: 21 CFR 862.1380
Advisory panel: Clinical Chemistry
Date received: 1977-10-27
Decision date: 1977-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMK

K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA6101999-12-27
K981865 — MTM BIOSCANNER K TEST STRIPS1999-02-26
K953452 — KETOREX C SANWA1996-05-02
K941427 — SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)1995-03-13
K862319 — HBDH (OPTIMIZED) REAGENT1986-07-07

More clearances from Harleco

K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
K813427 — ULTRACHEM GLUC-DH1981-12-31
K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

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