CROSSLAPS ELISA— 510(k) K972788

Name: FDA 510(k) clearance K972788
Creator: U.S. Food and Drug Administration
Published: 1998-12-22

Substantially Equivalent

Devices and Diagnostics Consulting Group

FDA 510(k) clearance K972788 for CROSSLAPS ELISA, Substantially Equivalent on 1998-12-22. Applicant: Devices and Diagnostics Consulting Group. Device class: 1.

Clearance details

Applicant: Devices and Diagnostics Consulting Group
Product code: Code JMM
Device class: Class 1
Regulation: 21 CFR 862.1400
Advisory panel: Clinical Chemistry
Date received: 1997-07-28
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMM

view all

K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE2001-07-30
K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY2000-07-24
K992997 — OSTEOMARK NTX POC1999-11-09
K990843 — SERUM CROSSLAPS ONE STEP ELISA1999-07-09
K983457 — OSTEOMARK NTX SERUM EIA1999-02-02

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