FACT* HOME PREGNANCY TEST— 510(k) K810581

Name: FDA 510(k) clearance K810581
Creator: U.S. Food and Drug Administration
Published: 1981-03-17

Substantially Equivalent

Ortho Pharmaceutical Corp.

FDA 510(k) clearance K810581 for FACT* HOME PREGNANCY TEST, Substantially Equivalent on 1981-03-17. Applicant: Ortho Pharmaceutical Corp.. Device class: 2.

Clearance details

Applicant: Ortho Pharmaceutical Corp.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1981-03-03
Decision date: 1981-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHJ

view all

K972606 — PREGNACOL PREGNANCY TEST1997-08-29
K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST1996-06-28
K935863 — SAS(TM) DIRECT MONOCLONAL HCG1994-02-24
K926112 — ACCUTEX BETA-HCG TEST1993-07-28
K930609 — SAS(TM) MONOCLONAL HCG-SLIDE1993-03-29

More clearances from Ortho Pharmaceutical Corp.

view all

K955648 — K-Y PERSONAL LUBRICANT1996-06-21
K934516 — ADVANCE PREGNANCY TEST MODIFICATION1994-02-24
K914990 — ADVANCE(R) PREGNANCY TEST1991-12-23
K893488 — PULSATILE PUMP FOR GONADORELIN ACETATE1989-10-31
K881151 — MICROSCRAPE1988-04-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.