The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Toxoplasma Igg Fast Elisa Assay (cat.#7560).
Device ID | K963297 |
510k Number | K963297 |
Device Name: | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Applicant | INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
Contact | Mary Frick |
Correspondent | Mary Frick INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 |
Product Code | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-21 |
Decision Date | 1996-12-16 |
Summary: | summary |