FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENT A AND REAGENT B
K Number: K874413
·
Decision Jan 5, 1988
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
28
Review Days
69
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Basic Information
- Device Name
- REAGENT A AND REAGENT B
- K Number
- K874413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Seradyn, Inc.
- Date Received
- October 28, 1987
- Decision Date
- January 5, 1988
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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Other Clearances by Seradyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K062204 | ARCHITECT CORTISOL ASSAY | Sep 22, 2006 | Substantially Equivalent |
| K060998 | QMS TOBRAMYCIN | Jul 21, 2006 | Substantially Equivalent |
| K060709 | MULTIGENT GENTAMICIN | Jun 15, 2006 | Substantially Equivalent |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Dec 23, 2005 | Substantially Equivalent |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Nov 18, 2005 | Substantially Equivalent |
| K052815 | QMS AMIKACIN REAGENTS | Nov 1, 2005 | Substantially Equivalent |
| K050419 | QMS VANCOMYCIN | Apr 1, 2005 | Substantially Equivalent |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Nov 3, 2004 | Substantially Equivalent |