FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNOPLATE III RADIO IMMUNODIFFUSION
K Number: K770548
·
Decision Apr 15, 1977
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
6
Applicant Total
44
Review Days
25
Basic Information
- Device Name
- IMMUNOPLATE III RADIO IMMUNODIFFUSION
- K Number
- K770548
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4800
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
- Date Received
- March 21, 1977
- Decision Date
- April 15, 1977
- Product Code
- JZQ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZQ | Plates And Equipment, Radial Immunodiffusion | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZQ), ordered by most recent decision date.
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Other Clearances by HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | Apr 26, 1982 | Substantially Equivalent |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Mar 11, 1982 | Substantially Equivalent |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Aug 18, 1981 | Substantially Equivalent |
| K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S | Feb 2, 1981 | Substantially Equivalent |
| K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. | Jan 28, 1981 | Substantially Equivalent |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Jan 5, 1981 | Substantially Equivalent |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Jun 28, 1979 | Substantially Equivalent |
| K790249 | TEST CELLS | May 16, 1979 | Substantially Equivalent |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Aug 31, 1978 | Substantially Equivalent |
| K780962 | AUTOMATED ENZYME | Jul 27, 1978 | Substantially Equivalent |