Submission Details
| 510(k) Number | K881500 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 1988 |
| Decision Date | April 27, 1988 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
Apr 1988
Decision
16d
Days
Class 1
Risk
About This 510(k) Submission
K881500 is an FDA 510(k) clearance for the ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on April 27, 1988, 16 days after receiving the submission on April 11, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.
Device Classification
| Product Code | LJP — Antiserum, Fluorescent, Chlamydia Trachomatis |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3120 |
Manufacturer
Similar Devices — LJP Antiserum, Fluorescent, Chlamydia Trachomatis
All 34
K063675 · Diagnostic Hybrids, Inc.
· Sep 2007
K941714 · Neogenex
· Jul 1994
K901243 · Cel Labs Pty, Ltd.
· May 1990
K900870 · Diagnostic Products Corp.
· Apr 1990
K895839 · Diagnostic Products Corp.
· Feb 1990
K883352 · Whittaker Bioproducts, Inc.
· Oct 1988
More from Ortho Diagnostic Systems, Inc.
View all
K951459
· GKZ · Jul 1997
K951632
· GKZ · Mar 1997
K964754
· GKZ · Jan 1997
K963902
· GIS · Nov 1996
K950568
· GKZ · May 1996