510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130915Substantially Equivalent

Xl-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack

JAS Diagnostics/Drew Scientific, Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130915 is the FDA 510(k) clearance record for XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK, a class I device, cleared for Jas Diagnostics, Inc. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list 20 510(k) clearances for JAS Diagnostics/Drew Scientific, from to . As of , FDA records show no recalls naming K130915.

Clearance record

Decision date
Received
(408 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Jas Diagnostics, Inc. 14100 NW 57th Ct., Miami Lakes FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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