FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K Number: K892801
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
145
Review Days
120
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Basic Information
- Device Name
- CLINISTAT TOTAL BILIRUBIN REAGENT TEST
- K Number
- K892801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- April 17, 1989
- Decision Date
- August 15, 1989
- Product Code
- CIG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
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