510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042750Substantially Equivalent

Qc-Beads

Bioscreen, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042750 is the FDA 510(k) clearance record for QC-BEADS, a class II device, cleared for Bioscreen, Inc. on under FDA product code NRF (Material, Quality Control, Semen Analysis). FDA's definition for product code NRF reads: "A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number...". FDA records list one 510(k) clearance for Bioscreen, Inc. As of , FDA records show no recalls naming K042750.

Clearance record

Decision date
Received
(25 days to decision)
Product code
NRF Material, Quality Control, Semen Analysis
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Bioscreen, Inc. 889 Broadway - Suite 6a, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code NRF

Trailing 12 months

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

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