510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170413Substantially Equivalent

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

Bio-Rad Laboratories Inc., Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170413 is the FDA 510(k) clearance record for BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set, a class II device, cleared for Bio-Rad Laboratories on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show 5 recalls naming K170413.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Bio-Rad Laboratories 5500 E. 2nd St., Benicia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIP

Trailing 12 months

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

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