The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Lactate Dehydrogenase Ldh.
| Device ID | K883206 |
| 510k Number | K883206 |
| Device Name: | LACTATE DEHYDROGENASE LDH |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1988-09-09 |