The following data is part of a premarket notification filed by David C. Bishop, Ph.d. with the FDA for Indx Dip-s-ticks Scrub Typhus Test For The Detection Of Igg And Igm Antibodies To Orientia Tsutsugamushi (scrub Typhus).
| Device ID | K971591 |
| 510k Number | K971591 |
| Device Name: | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) |
| Classification | Reagent, Rickettsia Serological |
| Applicant | DAVID C. BISHOP, PH.D. 605 DILWORTH RD. Downingtown, PA 19335 |
| Contact | David C Bishop |
| Correspondent | David C Bishop DAVID C. BISHOP, PH.D. 605 DILWORTH RD. Downingtown, PA 19335 |
| Product Code | LSQ |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1998-03-13 |
| Summary: | summary |