510(k) K092704
- Device
- ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
- Applicant
- ABBOTT MOLECULAR, INC.
- 510(k) number
- K092704
- Product code
- LSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-28
- Date received
- 2009-09-03
- Regulation
- 866.3120
- Classification name
- Dna-reagents, Chlamydia
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULA MARTIN
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 1122376
Source Documents#
Other 510(k) Records For Product Code LSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | Digene Corp. | 2001-09-25 |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | Digene Corp. | 2001-09-24 |
| K990023 | HYBRID CAPTURE II CT-ID TEST | Digene Corp. | 1999-10-25 |
| K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | Gen-Probe, Inc. | 1994-04-06 |
| K920378 | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | 1992-04-29 |
| K874878 | GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | 1987-12-29 |
| K871878 | RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | 1987-10-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary