LDH-INT TEST— 510(k) K771343

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K771343 for LDH-INT TEST, Substantially Equivalent on 1977-08-10. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code CFH
Device class: Class 2
Regulation: 21 CFR 862.1440
Advisory panel: Clinical Chemistry
Date received: 1977-07-20
Decision date: 1977-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFH

K050790 — SPOTCHEM II LDH TEST2005-06-06
K020484 — CARESIDE LDH2002-07-03
K895138 — CLINISTAT LDH REAGENT TEST1989-10-19
K894578 — IQ LDH1989-10-17
K880630 — LACTATE DEHYDROGENASE (LDH-L)1988-03-16

More clearances from Hycel, Inc.

K802422 — HYCEL TRIGYCERIDE II TEST1980-10-06
K790335 — HYCEL M1979-02-27
K782116 — KETOSTEROID TEST, HYCEL-171979-01-26
K782176 — HYCEL LDH-INT TEST1979-01-26
K782100 — HYCEL COUNTER 3331979-01-03

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