510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861974Substantially Equivalent

Perceptive Systems Inc Psicom 217 Karyotyping Syst

Perceptive Systems, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861974 is the FDA 510(k) clearance record for PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST, a class II device, cleared for Perceptive Systems, Inc. on under FDA product code LNJ (Analyzer, Chromosome, Automated). FDA records list 2 510(k) clearances for Perceptive Systems, Inc., from to . As of , FDA records show no recalls naming K861974.

Clearance record

Decision date
Received
(75 days to decision)
Product code
LNJ Analyzer, Chromosome, Automated
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Perceptive Systems, Inc. 1301 Regents Park Dr., Houston TX
Third party review
No

Clearances, product code LNJ

Trailing 12 months

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

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