FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE T UPTAKE REAGENT TU CALIBRATORS
K Number: K981375
·
Decision Jun 10, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
24
Review Days
55
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Basic Information
- Device Name
- ACE T UPTAKE REAGENT TU CALIBRATORS
- K Number
- K981375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiapparelli Biosystems, Inc.
- Date Received
- April 16, 1998
- Decision Date
- June 10, 1998
- Product Code
- KHQ
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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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 |
| 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 |