FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INDXTM DIP-S-TICKSTM
K Number: K920569
·
Decision Feb 9, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
3
Applicant Total
5
Review Days
368
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INDXTM DIP-S-TICKSTM
- K Number
- K920569
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intercare Diagnostics, Inc.
- Date Received
- February 7, 1992
- Decision Date
- February 9, 1993
- Product Code
- LSQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LSQ | Reagent, Rickettsia Serological | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSQ), ordered by most recent decision date.
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
FDA 510(k)
FDA Class 1
·Microbiology
INDX DIP S TICKS
FDA 510(k)
FDA Class 1
·Microbiology
LATEX R. CONORII
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Intercare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE | Aug 5, 1994 | Substantially Equivalent |
| K901597 | INDX DIP S TICKS | Dec 21, 1990 | Substantially Equivalent |
| K893895 | HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL | Jul 25, 1989 | Substantially Equivalent |
| K862948 | CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) | Oct 17, 1986 | Substantially Equivalent |