FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K Number: K991733
·
Decision Jul 13, 1999
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
24
Review Days
53
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Basic Information
- Device Name
- ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
- K Number
- K991733
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiapparelli Biosystems, Inc.
- Date Received
- May 21, 1999
- Decision Date
- July 13, 1999
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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Other Clearances by Schiapparelli Biosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | Nov 6, 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 |