510(k) K901597
- Device
- INDX DIP S TICKS
- Applicant
- INTERCARE DIAGNOSTICS, INC.
- 510(k) number
- K901597
- Product code
- LSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-21
- Date received
- 1990-04-05
- Regulation
- 866.3500
- Classification name
- Reagent, Rickettsia Serological
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELENE PAXTON
- Address
- P.O. Box 24124 Baltimore MD US 21227 21227
FDA Registration Numbers#
- 3004036192
- 3002800697
- 2023365
- 1034569
- 3014150341
- 2242436
- 2245285
- 3032562
- 2027113
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LSQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971591 | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) | David C. Bishop, Ph.D. | 1998-03-13 |
| K920569 | INDXTM DIP-S-TICKSTM | Intercare Diagnostics, Inc. | 1993-02-09 |
| K872129 | LATEX R. CONORII | Health Research, Inc. | 1987-08-19 |
Legacy Summary#
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FDA Review#
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