510(k) K915454

CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT by Medical Packaging Corp. — Product Code LIO

K915454 is an FDA 510(k) premarket notification submitted by Medical Packaging Corp. for the device "CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1992. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Medical Packaging Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1992
Date Received
December 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type