PREG BETA BLUS SLIDE— 510(k) K840833

Substantially Equivalent

Intl. Diagnostic, Inc.

FDA 510(k) clearance K840833 for PREG BETA BLUS SLIDE, Substantially Equivalent on 1984-05-30. Applicant: Intl. Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1984-02-24
Decision date: 1984-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHJ

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 Intl. Diagnostic, Inc.

K841853 — PREG-BETA ONE HOUR TUBE TEST1984-06-22
K834584 — NABI CRP-Q.S. TEST1984-02-27
K840005 — NABI RF-Q.S. TEST1984-02-13
K802343 — PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO1980-10-10
K780321 — PREGNANCY TEST KIT, OVER-THE-COUNTER1978-04-04

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