Cleared Traditional

CROSSLAPS ELISA

K972788 · Devices and Diagnostics Consulting Group · Chemistry

Dec 1998

Decision

512d

Days

Class 1

Risk

About This 510(k) Submission

K972788 is an FDA 510(k) clearance for the CROSSLAPS ELISA, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Devices and Diagnostics Consulting Group (Rockville, US). The FDA issued a Cleared decision on December 22, 1998, 512 days after receiving the submission on July 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number	K972788 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1997
Decision Date	December 22, 1998
Days to Decision	512 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF