SERUM CROSSLAPS ONE STEP ELISA— 510(k) K990843

Name: FDA 510(k) clearance K990843
Creator: U.S. Food and Drug Administration
Published: 1999-07-09

Substantially Equivalent

Osteometer Biotech A/S

FDA 510(k) clearance K990843 for SERUM CROSSLAPS ONE STEP ELISA, Substantially Equivalent on 1999-07-09. Applicant: Osteometer Biotech A/S. Device class: 1.

Clearance details

Applicant: Osteometer Biotech A/S
Product code: Code JMM
Device class: Class 1
Regulation: 21 CFR 862.1400
Advisory panel: Clinical Chemistry
Date received: 1999-03-15
Decision date: 1999-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herlev, DK

Download summary PDF View on FDA.gov ↗

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