The following data is part of a premarket notification filed by Portable Medical Laboratories, Inc. with the FDA for Hemoglobin Screening Device.
| Device ID | K882101 |
| 510k Number | K882101 |
| Device Name: | HEMOGLOBIN SCREENING DEVICE |
| Classification | Solution, Copper Sulfate For Specific Gravity Determinations |
| Applicant | PORTABLE MEDICAL LABORATORIES, INC. P.O. BOX 667 Solana Beach, CA 92075 |
| Contact | Warren R Sanborn |
| Correspondent | Warren R Sanborn PORTABLE MEDICAL LABORATORIES, INC. P.O. BOX 667 Solana Beach, CA 92075 |
| Product Code | KSL |
| CFR Regulation Number | 864.9320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-11 |
| Decision Date | 1988-07-01 |