510(k) K871671
- Device
- URINOSCOPY FUNNEL
- Applicant
- PORTABLE MEDICAL LABORATORIES, INC.
- 510(k) number
- K871671
- Product code
- GHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-20
- Date received
- 1987-04-28
- Regulation
- 864.6160
- Classification name
- Hemocytometer
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WARREN R SANBORN
- Address
- P.O. Box 667 Solana Beach CA US 92075 92075
FDA Registration Numbers#
- 3004765453
- 3014150341
- 3005273623
- 3030733800
- 3008496560
- 3017450368
- 3009092698
- 3027645317
- 3045058049
- 1067123
- 3019387954
- 3003750510
- 2410251
- 3003393069
- 3003799895
- 3010402713
- 2518612
- 2436787
- 3043088937
- 3016090200
- 3043138885
- 3010194621
- 3007349751
- 9614577
- 2031824
- 8030108
- 3009776283
- 3009155756
- 3014053517
- 9680411
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GHO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770980 | EMATOLOGY DILUENT RESERVOIR CLOSURE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-07-11 |
Legacy Summary#
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FDA Review#
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