510(k) K880417
- Device
- LEPTOSPIROSIS IHA
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K880417
- Product code
- GRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-12
- Date received
- 1988-02-01
- Regulation
- 866.3350
- Classification name
- Antigens, All, Leptospira Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MOORE, PHD
- Address
- 10703 Progress Way Cypress CA US 90630 90630
FDA Registration Numbers#
- 3004036192
- 3005360469
- 3002800697
- 3008191245
- 3014150341
- 3024463179
- 2029372
- 2245285
- 3005450604
- 2027113
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002024 | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA | Panbio, Inc. | 2000-11-22 |
Legacy Summary#
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FDA Review#
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