INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
FDA 510(k) clearance K971591 · decided 1998-03-13
Clearance details
- K-number
- K971591
- Device name
- INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
- Applicant
- David C. Bishop, Ph.D.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-01
- Decision date
- 1998-03-13
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- LSQ
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Dowingtown, PA, 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 |
|---|---|---|
| INDXTM DIP-S-TICKSTM (K920569) | Intercare Diagnostics, Inc. | 1993-02-09 |
| INDX DIP S TICKS (K901597) | Intercare Diagnostics, Inc. | 1990-12-21 |
| LATEX R. CONORII (K872129) | Health Research, Inc. | 1987-08-19 |
Recalls involving this device
No recalls on record reference this clearance.