The following data is part of a premarket notification filed by Healgen Scientific, Llc with the FDA for Healgen 11 Reagent Strip For Urinalysis, Healgen 10 Reagent Strip For Urinalysis, And Healgen 4 Reagent Strip For Urinal.
| Device ID | K111999 |
| 510k Number | K111999 |
| Device Name: | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | HEALGEN SCIENTIFIC, LLC 5213 MAPLE STREET Bellaire, TX 77401 |
| Contact | Yongquan Wang |
| Correspondent | Yongquan Wang HEALGEN SCIENTIFIC, LLC 5213 MAPLE STREET Bellaire, TX 77401 |
| Product Code | JIO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2012-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816490021104 | K111999 | 000 |
| 20816490020039 | K111999 | 000 |
| 20816490020022 | K111999 | 000 |
| 00850011007143 | K111999 | 000 |