Cleared Traditional

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

K981634 · Biocircuits Corp. · Immunology

Oct 1998

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K981634 is an FDA 510(k) clearance for the BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on October 13, 1998, 158 days after receiving the submission on May 8, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K981634 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1998
Decision Date	October 13, 1998
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010