IMMUNO-TEC II OT AGAROSE PLATE KIT
FDA 510(k) clearance K761270 · decided 1976-12-30
Clearance details
- K-number
- K761270
- Device name
- IMMUNO-TEC II OT AGAROSE PLATE KIT
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-16
- Decision date
- 1976-12-30
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JZP
- Device class
- 1
- Regulation number
- 866.4600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Behring Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |