The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Neopac Software, 3007 Digital Photometer/fluorometer Model Na, 307 And 350d.
| Device ID | K101392 |
| 510k Number | K101392 |
| Device Name: | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D |
| Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| Applicant | ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Contact | Jason C Reynolds |
| Correspondent | Jason C Reynolds ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Product Code | KQP |
| Subsequent Product Code | CDR |
| Subsequent Product Code | JBL |
| Subsequent Product Code | JIA |
| Subsequent Product Code | JJC |
| Subsequent Product Code | JNB |
| Subsequent Product Code | NAK |
| CFR Regulation Number | 862.1315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2011-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000519 | K101392 | 000 |
| 00725609000281 | K101392 | 000 |
| 00725609000298 | K101392 | 000 |
| 00725609000304 | K101392 | 000 |
| 00725609000311 | K101392 | 000 |
| 00725609000328 | K101392 | 000 |
| 00725609000335 | K101392 | 000 |
| 00725609000342 | K101392 | 000 |
| 00725609000359 | K101392 | 000 |
| 00725609000366 | K101392 | 000 |
| 00725609000373 | K101392 | 000 |
| 00725609000380 | K101392 | 000 |
| 00725609000397 | K101392 | 000 |
| 00725609000403 | K101392 | 000 |
| 00725609000410 | K101392 | 000 |
| 00725609000427 | K101392 | 000 |
| 00725609000434 | K101392 | 000 |
| 00725609000274 | K101392 | 000 |