FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYME FAST TEST
K Number: K883544
·
Decision Jan 13, 1989
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
109
Applicant Total
280
Review Days
147
Basic Information
- Device Name
- LYME FAST TEST
- K Number
- K883544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- 3M COMPANY
- Date Received
- August 19, 1988
- Decision Date
- January 13, 1989
- 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.
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 IgM ELISA 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 3M COMPANY
| K Number | Device Name | ||
|---|---|---|---|
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | Aug 14, 2017 | Substantially Equivalent |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | May 15, 2017 | Substantially Equivalent |
| K160546 | 3M Attest Rapid Readout Biological Indicator | Jun 9, 2016 | Substantially Equivalent |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | Dec 1, 2015 | Substantially Equivalent |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization | Jul 2, 2015 | Substantially Equivalent |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | Jan 8, 2015 | Substantially Equivalent |
| K140392 | 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER | Aug 13, 2014 | Substantially Equivalent |
| K123546 | 3M ATTEST(TM) AUTO-READER | Mar 18, 2013 | Substantially Equivalent |
| K121593 | 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK | Mar 15, 2013 | Substantially Equivalent |
| K123679 | 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING | Feb 28, 2013 | Substantially Equivalent |