FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
FDA 510(k) clearance K831902 · decided 1983-07-18
Clearance details
- K-number
- K831902
- Device name
- FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
- Applicant
- Dako Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-14
- Decision date
- 1983-07-18
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- DDZ
- Device class
- 2
- Regulation number
- 866.5040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (K050576) | Good Biotech Corp. | 2005-04-21 |
| MICROALBUMIN REAGENT SET AND CALIBRATORS (K023860) | Pointe Scientific, Inc., | 2003-04-28 |
| RANDOX MICROALBUMIN (K002674) | Randox Laboratories, Ltd. | 2000-10-05 |
Recalls involving this device
No recalls on record reference this clearance.