510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911839Substantially Equivalent

Neonatal Blood Spot Test 17-Hydroxprog Radio Kit

Pantex, Div. Bio-Analysis, Inc., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911839 is the FDA 510(k) clearance record for NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT, a class I device, cleared for Pantex, Div. Bio-Analysis, Inc. on under FDA product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone). FDA records list 16 510(k) clearances for Pantex, Div. Bio-Analysis, Inc., from to . As of , FDA records show no recalls naming K911839.

Clearance record

Decision date
Received
(54 days to decision)
Product code
JLX Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Pantex, Div. Bio-Analysis, Inc. 1737 21st St., Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code JLX

Trailing 12 months

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

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