510(k) K853401
- Device
- CHLAMYSET ANTIGEN
- Applicant
- ORION CORP.
- 510(k) number
- K853401
- Product code
- LJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-28
- Date received
- 1985-08-12
- Regulation
- 866.3120
- Classification name
- Antiserum, Fluorescent, Chlamydia Trachomatis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMO RAINES
- Address
- P.O. Box 425 20101 Turku FI
FDA Registration Numbers#
- 3003750284
- 1528450
- 8010096
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K063675 | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | Diagnostic Hybrids, Inc. | 2007-09-24 |
| K941714 | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | Neogenex | 1994-07-18 |
| K901243 | CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST | Cel Labs Pty, Ltd. | 1990-05-21 |
| K900870 | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST | Diagnostic Products Corp. | 1990-04-16 |
| K895839 | PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 | Diagnostic Products Corp. | 1990-02-01 |
| K883352 | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI | Whittaker Bioproducts, Inc. | 1988-10-06 |
| K881500 | ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST | Ortho Diagnostic Systems, Inc. | 1988-04-27 |
| K880031 | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-17 |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Orion Corp. | 1987-09-22 |
| K872903 | MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. | Syva Co. | 1987-08-06 |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | Serono Diagnostics, Inc. | 1987-04-29 |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Diagnostic Technology, Inc. | 1987-04-29 |
| K871278 | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 |
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | American Micro Scan | 1987-03-25 |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1987-03-12 |
Legacy Summary#
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FDA Review#
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