FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DYNAZYME II Y-GT
K Number: K771084
·
Decision Aug 4, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
54
Review Days
49
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Basic Information
- Device Name
- DYNAZYME II Y-GT
- K Number
- K771084
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- J.T. Baker Chemical Co.
- Date Received
- June 16, 1977
- Decision Date
- August 4, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | Sep 16, 1980 | Substantially Equivalent |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | Sep 16, 1980 | Substantially Equivalent |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | Sep 16, 1980 | Substantially Equivalent |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | Jul 21, 1980 | Substantially Equivalent |
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