TAGO FIFFU-GEN, OROSOMUCOID
FDA 510(k) clearance K841734 · decided 1984-06-01
Clearance details
- K-number
- K841734
- Device name
- TAGO FIFFU-GEN, OROSOMUCOID
- Applicant
- Tago, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-26
- Decision date
- 1984-06-01
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LKL
- Device class
- 1
- Regulation number
- 866.5420
- 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 |
|---|---|---|
| K-ASSAY ALPHA-1 AG (K993441) | Kamiya Biomedical Co. | 1999-11-24 |
| N-ASSAY TIA MULTI V-NL (K964299) | Crestat Diagnostics, Inc. | 1997-07-14 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (K964257) | Beckman Instruments, Inc. | 1997-03-24 |
| AL-ACID GLYCOPROTEIN RID KIT (K922417) | The Binding Site, Ltd. | 1992-08-20 |
| RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (K904175) | Reagents Applications, Inc. | 1990-11-13 |
| TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (K884217) | Technicon Instruments Corp. | 1988-11-04 |
| ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (K873868) | Unipath , Ltd. | 1987-10-20 |
| SANTEST 1AP (K862087) | Scientific Sales Intl., Inc. | 1986-12-03 |
| IAP PLATE TEST (K861336) | Scientific Sales Intl., Inc. | 1986-04-25 |
| TEST FOR HUMAN ALPHA ONE ACID GLYCO- (K831960) | Kent Laboratories, Inc. | 1983-07-19 |
Recalls involving this device
No recalls on record reference this clearance.