510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062534Substantially Equivalent

Enzyme Immunoassay for the Detection of Salivary 17-a-Hydroxyprogesterone

Drg Intl., Inc., East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062534 is the FDA 510(k) clearance record for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE, a class I device, cleared for Drg Intl., Inc. on under FDA product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone). FDA records list 4 510(k) clearances for Drg Intl., Inc., from to . As of , FDA records show no recalls naming K062534.

Clearance record

Decision date
Received
(518 days to decision)
Product code
JLX Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Drg Intl., Inc. 150 Cherry Ln. Rd., East Stroudsburg PA
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