510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213987Substantially Equivalent

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

Biokit, S.A., Lliçà D´Amunt, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213987 is the FDA 510(k) clearance record for ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls, a class II device, cleared for Biokit, S.A. on under FDA product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1). FDA records list 23 510(k) clearances for Biokit, S.A., from to . As of , FDA records show no recalls naming K213987.

Clearance record

Decision date
Received
(639 days to decision)
Product code
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Biokit, S.A. Av. Can Montcau 7, Lliçà D´Amunt, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXJ

Trailing 12 months

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

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