510(k) K920378
- Device
- PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K920378
- Product code
- LSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-29
- Date received
- 1992-01-29
- 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
- RUBEN CHAIREZ
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 1122376
Source Documents#
Other 510(k) Records For Product Code LSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | Abbott Molecular, Inc. | 2010-05-28 |
| 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 |
| 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#
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FDA Review#
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