510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843622Substantially Equivalent

Abbott Hsv Eia

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843622 is the FDA 510(k) clearance record for ABBOTT HSV EIA, a class II device, cleared for Abbott Laboratories on under FDA product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K843622.

Clearance record

Decision date
Received
(248 days to decision)
Product code
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code LGC

Trailing 12 months

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

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