The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Crithidia Lucilliae Ds Dna Kit (diagnostic Use).
| Device ID | K930987 |
| 510k Number | K930987 |
| Device Name: | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-25 |
| Decision Date | 1993-08-10 |