Indx Dip S Ticks
FDA 510(k) K901597 · Intercare Diagnostics, Inc.
510(k) numberK901597
Submission
- Device name
- Indx Dip S Ticks
- Applicant
- Intercare Diagnostics, Inc.
Baltimore, MD, US - Received
- April 5, 1990
- Decision date
- December 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LSQ – Reagent, Rickettsia Serological
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3500
- Specialty
- Microbiology
Other 510(k)s with product code LSQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971591 | Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to…LSQ · Traditional | David C. Bishop, Ph.D. | 03/13/1998SE |
| K920569 | Indxtm Dip-S-TickstmLSQ · Traditional | Intercare Diagnostics, Inc. | 02/09/1993SE |
| K872129 | Latex R. ConoriiLSQ · Traditional | Health Research, Inc. | 08/19/1987SE |
More from Health Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941938 | The Mirage System Biofeedback InterfaceHCC · Traditional | 08/05/1994SE |
| K920569 | Indxtm Dip-S-TickstmLSQ · Traditional | 02/09/1993SE |
| K893895 | Hematology Control Mixtures for Quality ControlJPK · Traditional | 07/25/1989SE |
| K862948 | Chlamydia Tissue Culture Confirmation Test (Eia)LJC · Traditional | 10/17/1986SE |
Questions and answers
When was Indx Dip S Ticks cleared by the FDA?
Indx Dip S Ticks (K901597) received a 510(k) decision of Substantially Equivalent on December 21, 1990, 260 days after the submission was received.
What is the product code of K901597?
The FDA product code is LSQ – Reagent, Rickettsia Serological, a Class I (low risk) device regulated under 21 CFR 866.3500.