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
K913664Substantially Equivalent

Rosys Models 100 and 200

Packard Instrument Co., Inc., Downers Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913664 is the FDA 510(k) clearance record for ROSYS MODELS 100 AND 200, a class I device, cleared for Packard Instrument Co., Inc. on under FDA product code JQW (Station, Pipetting And Diluting, For Clinical Use). FDA records list 4 510(k) clearances for Packard Instrument Co., Inc., from to . As of , FDA records show no recalls naming K913664.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
Regulation
21 CFR 862.2750
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Packard Instrument Co., Inc. 2200 Warrenville Rd., Downers Grove IL
510(k) summary
Statement
Third party review
No

Clearances, product code JQW

Trailing 12 months

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

FDA records show no clearances under product code JQW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQW, 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