FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYME DISEASE IFA (IGM)
K Number: K883767
·
Decision Mar 15, 1989
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
33
Review Days
190
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Basic Information
- Device Name
- LYME DISEASE IFA (IGM)
- K Number
- K883767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hillcrest Biologicals
- Date Received
- September 6, 1988
- Decision Date
- March 15, 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 |
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Other Clearances by Hillcrest Biologicals
| K Number | Device Name | ||
|---|---|---|---|
| K913618 | ARBOVIRUS IGM IFA TEST | Dec 3, 1992 | Substantially Equivalent |
| K913617 | ARBOVIRUS IGG IFA TEST | Dec 3, 1992 | Substantially Equivalent |
| K913906 | Q FEVER IGG IFA TEST | Oct 21, 1992 | Substantially Equivalent |
| K922374 | Q FEVER IGM IFA TEST | Oct 21, 1992 | Substantially Equivalent |
| K900206 | LYME DISEASE IGM ELISA | Jun 28, 1991 | Substantially Equivalent |
| K896594 | EBV VCA ANTIBODY (IGM) | Jan 16, 1990 | Substantially Equivalent |
| K884829 | EBV EARLY ANTIGEN (R+D) | Apr 12, 1989 | Substantially Equivalent |
| K884591 | EBV-VCA ANTIBODY (IGG) | Jan 24, 1989 | Substantially Equivalent |
| K883487 | LYME DISEASE IFA (IGG) | Dec 13, 1988 | Substantially Equivalent |
| K875170 | EBNA ANTIBODY | May 23, 1988 | Substantially Equivalent |