The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Ldh Test.
| Device ID | K050790 |
| 510k Number | K050790 |
| Device Name: | SPOTCHEM II LDH TEST |
| Classification | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Applicant | ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | CFH |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2005-06-06 |
| Summary: | summary |