510(k) K844475

SPECIMEN COLLECTION & TRANSPORT SYSTEM by Portable Medical Laboratories, Inc. — Product Code FMF

K844475 is an FDA 510(k) premarket notification submitted by Portable Medical Laboratories, Inc. for the device "SPECIMEN COLLECTION & TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 6, 1985. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Portable Medical Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1985
Date Received
November 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type