FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CK-MB IMMUNOASSAY CONTROL
K Number: K905623
·
Decision Feb 22, 1991
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
28
Review Days
70
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Basic Information
- Device Name
- CK-MB IMMUNOASSAY CONTROL
- K Number
- K905623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Seradyn, Inc.
- Date Received
- December 14, 1990
- Decision Date
- February 22, 1991
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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FDA 510(k)
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Other Clearances by Seradyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | May 17, 2007 | Substantially Equivalent |
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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 |