510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K821937Substantially Equivalent

Syva Advance Standardization Kit #2

Syva Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821937 is the FDA 510(k) clearance record for SYVA ADVANCE STANDARDIZATION KIT #2, a class II device, cleared for Syva Co. on under FDA product code JIS (Calibrator, Primary). FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K821937.

Clearance record

Decision date
Received
(17 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Syva Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JIS

Trailing 12 months

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

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