510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921868Substantially Equivalent

Endocrine Sciences Products Igfbp3 Radioimmuno Kit

Endocrine Sciences Products, Calabasas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921868 is the FDA 510(k) clearance record for ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT, a class I device, cleared for Endocrine Sciences Products on under FDA product code CFL (Radioimmunoassay, Human Growth Hormone). FDA records list 2 510(k) clearances for Endocrine Sciences Products, from to . As of , FDA records show no recalls naming K921868.

Clearance record

Decision date
Received
(623 days to decision)
Product code
CFL Radioimmunoassay, Human Growth Hormone
Regulation
21 CFR 862.1370
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Endocrine Sciences Products 4301 Lost Hills Rd., Calabasas CA
510(k) summary
Statement
Third party review
No

Clearances, product code CFL

Trailing 12 months

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

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