FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYME-CHECK(TM) TEST KIT
K Number: K896378
·
Decision Nov 5, 1991
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
28
Review Days
729
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
- LYME-CHECK(TM) TEST KIT
- K Number
- K896378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Technology, Inc.
- Date Received
- November 6, 1989
- Decision Date
- November 5, 1991
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSR), ordered by most recent decision date.
Lyme-ID IgG Test; Bio-ID800
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgM ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
iDart Lyme IgG ImmunoBlot Kit
FDA 510(k)
FDA Class 2
·Microbiology
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
Viramed Borrela All-In-One ViraChip Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Diagnostic Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903612 | EBV/EA-CHECK TM TEST KIT | Oct 16, 1990 | Substantially Equivalent |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K891542 | EBNA-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K890819 | HSV-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Jun 25, 1987 | Substantially Equivalent |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Apr 29, 1987 | Substantially Equivalent |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Nov 28, 1986 | Substantially Equivalent |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | May 7, 1986 | Substantially Equivalent |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Apr 4, 1986 | Substantially Equivalent |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | Nov 5, 1985 | Substantially Equivalent |