The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Latex Agglutination Test.
| Device ID | K851132 |
| 510k Number | K851132 |
| Device Name: | LATEX AGGLUTINATION TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 10220 OLD COLUMBIA RD. Columbia, MD 21046 |
| Contact | Lawrence Loomis |
| Correspondent | Lawrence Loomis NEW HORIZONS DIAGNOSTICS CO. 10220 OLD COLUMBIA RD. Columbia, MD 21046 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-07-05 |