FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL BILIRUBIN REAGENT
K Number: K881241
·
Decision May 27, 1988
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
233
Applicant Total
20
Review Days
66
Basic Information
- Device Name
- TOTAL BILIRUBIN REAGENT
- K Number
- K881241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- TECH-NEAL SCIENTIFIC, INC.
- Date Received
- March 22, 1988
- Decision Date
- May 27, 1988
- 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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Other Clearances by TECH-NEAL SCIENTIFIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | Aug 8, 1988 | Substantially Equivalent |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Aug 2, 1988 | Substantially Equivalent |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | May 31, 1988 | Substantially Equivalent |
| K881240 | CHLORIDE REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880237 | CHOLESTEROL | Apr 28, 1988 | Substantially Equivalent |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880277 | URIC ACID REAGENT SET | Apr 18, 1988 | Substantially Equivalent |
| K880845 | CALCIUM REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880842 | LDH-L REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880843 | CREATININE REAGENT SET (KINETIC) | Apr 5, 1988 | Substantially Equivalent |