FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER
K Number: K942250
·
Decision Apr 4, 1995
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
10
Review Days
330
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Basic Information
- Device Name
- BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER
- K Number
- K942250
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biowhittaker Molecular Applications, Inc.
- Date Received
- May 9, 1994
- Decision Date
- April 4, 1995
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Biowhittaker Molecular Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943843 | VARICELISA, MODIFICATION | Mar 14, 1996 | Substantially Equivalent |
| K942361 | WHITSOFT | Apr 4, 1995 | Substantially Equivalent |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Apr 3, 1995 | Substantially Equivalent |
| K925209 | MUMPS STAT | Oct 14, 1994 | Substantially Equivalent |
| K935618 | SPECIMEN TRANSPORT MEDIUM | Apr 21, 1994 | Substantially Equivalent |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | Aug 23, 1993 | Substantially Equivalent |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | Mar 26, 1993 | Substantially Equivalent |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | Mar 23, 1993 | Substantially Equivalent |
| K920753 | RF STAT IGM TEST KIT | Mar 30, 1992 | Substantially Equivalent |