510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961317Substantially Equivalent

Syphilis Igm Human Serum Controls

Pyramid Biological Corp., Van Nuys CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961317 is the FDA 510(k) clearance record for SYPHILIS IGM HUMAN SERUM CONTROLS, a class II device, cleared for Pyramid Biological Corp. on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 12 510(k) clearances for Pyramid Biological Corp., from to . As of , FDA records show no recalls naming K961317.

Clearance record

Decision date
Received
(80 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
Pyramid Biological Corp. 6454 Van Nuys Blvd., Suite 111, Van Nuys CA
510(k) summary
Statement
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