510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002128Substantially Equivalent

Active Inhibin-a Elisa, Model Dsl-10-28100

Diagnostic Systems Laboratories, Inc., Webster TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002128 is the FDA 510(k) clearance record for ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100, a class I device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code NDR (Enzyme Immunoassay, Inhibin-A). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show 4 recalls naming K002128.

Clearance record

Decision date
Received
(144 days to decision)
Product code
NDR Enzyme Immunoassay, Inhibin-A
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd., Webster TX
510(k) summary
Summary
Third party review
No

Clearances, product code NDR

Trailing 12 months

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

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