FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT BILIRUBIN REAGENT
K Number: K011972
·
Decision Aug 27, 2001
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
21
Review Days
63
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Basic Information
- Device Name
- DIRECT BILIRUBIN REAGENT
- K Number
- K011972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intersect Systems, Inc.
- Date Received
- June 25, 2001
- Decision Date
- August 27, 2001
- 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 Intersect Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021636 | ALBUMIN REAGENT | Jul 17, 2002 | Substantially Equivalent |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Jul 25, 2001 | Substantially Equivalent |
| K003892 | TOTAL BILIRUBIN REAGENT | Feb 20, 2001 | Substantially Equivalent |
| K983937 | DUAL VIAL CREATININE REAGENT | Jan 6, 1999 | Substantially Equivalent |
| K974833 | CK-NAC REAGENT | Feb 13, 1998 | Substantially Equivalent |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Sep 14, 1994 | Substantially Equivalent |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | Jan 31, 1994 | Substantially Equivalent |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | Nov 16, 1993 | Substantially Equivalent |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | Sep 24, 1993 | Substantially Equivalent |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | Oct 11, 1991 | Substantially Equivalent |