The following data is part of a premarket notification filed by Strategic Diagnostics, Inc. with the FDA for Macralp(a) Enzyme Immunoassay Kit.
| Device ID | K971157 |
| 510k Number | K971157 |
| Device Name: | MACRALP(A) ENZYME IMMUNOASSAY KIT |
| Classification | Electrophoretic Separation, Lipoproteins |
| Applicant | STRATEGIC DIAGNOSTICS, INC. 128 SANDY DR. Newark, DE 19713 |
| Contact | Joseph X Dautlick |
| Correspondent | Joseph X Dautlick STRATEGIC DIAGNOSTICS, INC. 128 SANDY DR. Newark, DE 19713 |
| Product Code | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1998-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743938 | K971157 | 000 |