The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for J&s Hdl Cholesterol Precipitating Reagent.
| Device ID | K900218 |
| 510k Number | K900218 |
| Device Name: | J&S HDL CHOLESTEROL PRECIPITATING REAGENT |
| Classification | Tube, Tympanostomy, Porous Polyethylene |
| Applicant | J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Marshall E Deutsch |
| Correspondent | Marshall E Deutsch J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | LBL |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-06-18 |