The following data is part of a premarket notification filed by J & S Medical Assoc., Inc. with the FDA for J&s Medical Sentry Urine Dipstick Control.
| Device ID | K022085 |
| 510k Number | K022085 |
| Device Name: | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | J & S MEDICAL ASSOC., INC. 35 TRIPP ST., BLDG. #1 Framingham, MA 01702 |
| Contact | Paul Macdonnell |
| Correspondent | Paul Macdonnell J & S MEDICAL ASSOC., INC. 35 TRIPP ST., BLDG. #1 Framingham, MA 01702 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-27 |
| Decision Date | 2002-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883006362 | K022085 | 000 |