FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
K Number: K973536
·
Decision Nov 6, 1997
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
122
Applicant Total
24
Review Days
49
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Basic Information
- Device Name
- ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
- K Number
- K973536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiapparelli Biosystems, Inc.
- Date Received
- September 18, 1997
- Decision Date
- November 6, 1997
- Product Code
- DLJ
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | FDA class 2 | Clinical Toxicology |
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Other Clearances by Schiapparelli Biosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Jul 13, 1999 | Substantially Equivalent |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Jun 10, 1998 | Substantially Equivalent |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Jun 10, 1998 | Substantially Equivalent |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Nov 12, 1997 | Substantially Equivalent |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Nov 4, 1997 | Substantially Equivalent |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Oct 20, 1997 | Substantially Equivalent |
| K971526 | ACE HDL-C REAGENT | May 21, 1997 | Substantially Equivalent |
| K954179 | HDL PRECIPITATING REAGENT | Dec 11, 1995 | Substantially Equivalent |