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
K910302Substantially Equivalent

Eclipse Ica Analyzer

Biotope, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910302 is the FDA 510(k) clearance record for ECLIPSE ICA ANALYZER, a class I device, cleared for Biotope, Inc. on under FDA product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use). FDA records list 7 510(k) clearances for Biotope, Inc., from to . As of , FDA records show no recalls naming K910302.

Clearance record

Decision date
Received
(29 days to decision)
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Regulation
21 CFR 862.2300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Biotope, Inc. 12277 134th Ct., NE, Redmond WA
Third party review
No

Clearances, product code JJQ

Trailing 12 months

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

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