510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790588Substantially Equivalent

Assay Reagents, Lsa 290

Kallestad Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790588 is the FDA 510(k) clearance record for ASSAY REAGENTS, LSA 290, a class I device, cleared for Kallestad Laboratories, Inc. on under FDA product code JEW (Tip, Rubber, Oral Hygiene). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K790588.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JEW Tip, Rubber, Oral Hygiene
Regulation
21 CFR 872.6650
Device class
Class I
Review panel
Dental
Applicant
Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JEW

Trailing 12 months

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

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