510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970008Substantially Equivalent

Advanced Quality Pregnancy Test

Bionike, Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970008 is the FDA 510(k) clearance record for ADVANCED QUALITY PREGNANCY TEST, a class II device, cleared for Bionike, Inc. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 2 510(k) clearances for Bionike, Inc., from to . As of , FDA records show no recalls naming K970008.

Clearance record

Decision date
Received
(47 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bionike, Inc. 1015 Grandview Dr., South San Francisco CA
510(k) summary
Statement
Third party review
No

Clearances, product code LCX

Trailing 12 months

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

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