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
K030525Substantially Equivalent

Custom Products Ivf Workstation Type Wkst-24*36, Wkst-24*48, Wkst-24*60, Wkst-24*72 and Wkst-24*72D Plus Accessories

Mid-Atlantic Diagnostics, Inc., Marlton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K030525 is the FDA 510(k) clearance record for CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES, a class II device, cleared for Mid-Atlantic Diagnostics, Inc. on under FDA product code MQG (Accessory, Assisted Reproduction). FDA records list 4 510(k) clearances for Mid-Atlantic Diagnostics, Inc., from to . As of , FDA records show no recalls naming K030525.

Clearance record

Decision date
Received
(189 days to decision)
Product code
MQG Accessory, Assisted Reproduction
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mid-Atlantic Diagnostics, Inc. 438 N. Elmwood Rd., Marlton NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MQG

Trailing 12 months
2 clearances under product code MQG in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260