Atlas FDA

CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

FDA 510(k) clearance K864662 · decided 1987-03-25

Clearance details

K-number
K864662
Device name
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
Applicant
American Micro Scan
Decision
Substantially Equivalent
Date received
1986-11-28
Decision date
1987-03-25
Days to decision
117 days
Clearance type
Traditional
Product code
LJP
Device class
1
Regulation number
866.3120
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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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.

PMA approvals by this applicant

RecordFirmDate
MIC PANELS (N62160/S013)American Micro Scan1985-03-05
MIC PANELS (N62160/S011)American Micro Scan1984-01-30
MIC PANELS (N62160/S012)American Micro Scan1984-01-30
MIC PANELS (N62160/S010)American Micro Scan1983-10-12
MIC PANELS (N62160/S009)American Micro Scan1983-09-28
MIC PANELS (N62160/S008)American Micro Scan1983-08-10
MIC PANELS (N62160/S007)American Micro Scan1983-02-03
MIC PANELS (N62160/S006)American Micro Scan1982-11-18