FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
K Number: K850411
·
Decision May 8, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
50
Review Days
93
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
- K Number
- K850411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- February 4, 1985
- Decision Date
- May 8, 1985
- Product Code
- LGP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LGP | Assay, Alpha-2-Antiplasmin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGP), ordered by most recent decision date.
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
FDA 510(k)
FDA Class 2
·Hematology
COATEST ANTIPLASMIN
FDA 510(k)
FDA Class 2
·Hematology
PROTEOLYTIC ENZYME CONTROL
FDA 510(k)
FDA Class 2
·Hematology
ALPHA-ANTIPLASM ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Warner-Lambert Co.
| K Number | Device Name | ||
|---|---|---|---|
| K024160 | NEOSPORIN SCAR SOLUTION | Mar 17, 2003 | Substantially Equivalent |
| K893452 | EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM | Jun 22, 1989 | Substantially Equivalent |
| K870584 | O.P.T.(TM) OVULATION PREDICTION TEST | Nov 25, 1987 | Substantially Equivalent |
| K861510 | MULTILUMEN VIAPIC CENTRAL LINE CATHETER | Jun 9, 1986 | Substantially Equivalent |
| K852689 | GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK | Aug 19, 1985 | Substantially Equivalent |
| K852967 | GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK | Aug 19, 1985 | Substantially Equivalent |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Aug 13, 1985 | Substantially Equivalent |
| K852889 | GENERAL DIAGNOSTICS RAPID E. COLI TEST | Jul 23, 1985 | Substantially Equivalent |
| K850409 | GEN. DIAG. CHROMOSTRATE REF. PLASMA | May 8, 1985 | Substantially Equivalent |
| K850412 | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY | May 8, 1985 | Substantially Equivalent |