FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIAX LYME M TEST KIT
K Number: K904893
·
Decision Oct 16, 1991
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
30
Review Days
351
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Basic Information
- Device Name
- FIAX LYME M TEST KIT
- K Number
- K904893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Whittaker Bioproducts, Inc.
- Date Received
- October 30, 1990
- Decision Date
- October 16, 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 |
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Other Clearances by Whittaker Bioproducts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Jul 30, 1992 | Substantially Equivalent |
| K913212 | 3M IGE SINGLE POINT FAST TEST | Nov 22, 1991 | Substantially Equivalent |
| K904652 | LYME STAT M TEST KIT | Oct 21, 1991 | Substantially Equivalent |
| K911473 | EBNA STAT TEST KIT | Sep 25, 1991 | Substantially Equivalent |
| K905468 | PYLORI-G FIAX TEST KIT | May 7, 1991 | Substantially Equivalent |
| K904738 | PYLORI STAT TEST KIT | May 7, 1991 | Substantially Equivalent |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Jun 27, 1990 | Substantially Equivalent |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Jan 16, 1990 | Substantially Equivalent |
| K894932 | FIAX EB VCA-M TEST KIT | Oct 16, 1989 | Substantially Equivalent |
| K894235 | EB VCA STAT M TEST KIT | Aug 30, 1989 | Substantially Equivalent |