510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K982156Substantially Equivalent

Pasco Mic and Mic/id Panels/ Cefdinir

Pasco Laboratories, Inc., Wheat Ridge CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982156 is the FDA 510(k) clearance record for PASCO MIC AND MIC/ID PANELS/ CEFDINIR, a class II device, cleared for Pasco Laboratories, Inc. on under FDA product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained). FDA records list 66 510(k) clearances for Pasco Laboratories, Inc., from to . As of , FDA records show no recalls naming K982156.

Clearance record

Decision date
Received
(41 days to decision)
Product code
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Regulation
21 CFR 888.3800
Device class
Class II
Review panel
Orthopedic
Applicant
Pasco Laboratories, Inc. 12750 W. 42nd Ave., Wheat Ridge CO
510(k) summary
Summary
Third party review
No

Clearances, product code JWJ

Trailing 12 months

FDA records hold no clearances under product code JWJ in the trailing twelve months.

FDA records show no clearances under product code JWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260