Atlas FDA

MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT

FDA 510(k) clearance K842623 · decided 1984-08-02

Clearance details

K-number
K842623
Device name
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
Applicant
Syva Co.
Decision
Substantially Equivalent
Date received
1984-07-05
Decision date
1984-08-02
Days to decision
28 days
Clearance type
Traditional
Product code
LJP
Device class
1
Regulation number
866.3120
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Syva Co.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675)Diagnostic Hybrids, Inc.2007-09-24
CHLAMYDIA TRACHOMATIS ANTIGEN TEST (K941714)Neogenex1994-07-18
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (K901243)Cel Labs Pty, Ltd.1990-05-21
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (K900870)Diagnostic Products Corp.1990-04-16
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (K895839)Diagnostic Products Corp.1990-02-01
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (K883352)Whittaker Bioproducts, Inc.1988-10-06
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (K881500)Ortho Diagnostic Systems, Inc.1988-04-27
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (K880031)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-17
MODIFIED CHLAMYSET ANTIGEN (K872744)Orion Corp.1987-09-22
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (K872903)Syva Co.1987-08-06
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST (K870946)Serono Diagnostics, Inc.1987-04-29
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (K864128)Diagnostic Technology, Inc.1987-04-29

Recalls involving this device

No recalls on record reference this clearance.