510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851521Substantially Equivalent

Ld-1(Immuno) Separation Set

Seragen Diagnostics, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851521 is the FDA 510(k) clearance record for LD-1(IMMUNO) SEPARATION SET, a class II device, cleared for Seragen Diagnostics, Inc. on under FDA product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes). FDA records list 20 510(k) clearances for Seragen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K851521.

Clearance record

Decision date
Received
(25 days to decision)
Product code
CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Seragen Diagnostics, Inc. P.O. Box 1210, Indianapolis IN
Third party review
No

Clearances, product code CEX

Trailing 12 months

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

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