The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Hcy, N Protein Standard Sl, N/t Protein Control L/m/h.
| Device ID | K052788 |
| 510k Number | K052788 |
| Device Name: | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | LPS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007590 | K052788 | 000 |
| 00842768006715 | K052788 | 000 |
| 00630414285061 | K052788 | 000 |
| 00842768016134 | K052788 | 000 |
| 00842768016127 | K052788 | 000 |
| 00842768016110 | K052788 | 000 |