FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTEOLYTIC ENZYME CONTROL
K Number: K803110
·
Decision Feb 17, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
149
Review Days
69
Basic Information
- Device Name
- PROTEOLYTIC ENZYME CONTROL
- K Number
- K803110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN DADE
- Date Received
- December 10, 1980
- Decision Date
- February 17, 1981
- Product Code
- LGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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
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GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
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FDA Class 2
·Hematology
COATEST ANTIPLASMIN
FDA 510(k)
FDA Class 2
·Hematology
ALPHA-ANTIPLASM ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by AMERICAN DADE
| K Number | Device Name | ||
|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | Oct 20, 1987 | Substantially Equivalent |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 29, 1987 | Substantially Equivalent |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 14, 1987 | Substantially Equivalent |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | Sep 2, 1987 | Substantially Equivalent |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | Aug 6, 1987 | Substantially Equivalent |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | Jul 31, 1987 | Substantially Equivalent |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | Jul 6, 1987 | Substantially Equivalent |