LATEX R. CONORII
FDA 510(k) clearance K872129 · decided 1987-08-19
Clearance details
- K-number
- K872129
- Device name
- LATEX R. CONORII
- Applicant
- Health Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-02
- Decision date
- 1987-08-19
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LSQ
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Albany, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) (K971591) | David C. Bishop, Ph.D. | 1998-03-13 |
| INDXTM DIP-S-TICKSTM (K920569) | Intercare Diagnostics, Inc. | 1993-02-09 |
| INDX DIP S TICKS (K901597) | Intercare Diagnostics, Inc. | 1990-12-21 |
Recalls involving this device
No recalls on record reference this clearance.