510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780467Substantially Equivalent

Emit Antiepileptic Drug Calibrators

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

K780467 is the FDA 510(k) clearance record for EMIT ANTIEPILEPTIC DRUG CALIBRATORS, a class II device, cleared for Syva Co. on under FDA product code JIS (Calibrator, Primary). FDA records list 33 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K780467.

Clearance record

Decision date
Received
(33 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Syva Co. 4221 Richmond Rd., NW, Walker MI
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