Cleared Traditional

SERUM CROSSLAPS ONE STEP ELISA

K990843 · Osteometer Biotech A/S · Chemistry

Jul 1999

Decision

116d

Days

Class 1

Risk

About This 510(k) Submission

K990843 is an FDA 510(k) clearance for the SERUM CROSSLAPS ONE STEP ELISA, a Column Chromatography & Color Development, Hydroxyproline (Class I — General Controls, product code JMM), submitted by Osteometer Biotech A/S (Herlev, DK). The FDA issued a Cleared decision on July 9, 1999, 116 days after receiving the submission on March 15, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1400.

Submission Details

510(k) Number	K990843 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 1999
Decision Date	July 09, 1999
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF