FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULFATE, FIBRIQUIK PROTAMINE
K Number: K781814
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
39
Review Days
13
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Basic Information
- Device Name
- SULFATE, FIBRIQUIK PROTAMINE
- K Number
- K781814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7300
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- General Diagnostics
- Date Received
- October 26, 1978
- Decision Date
- November 8, 1978
- Product Code
- JBN
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JBN | Fibrin Monomer Paracoagulation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBN), ordered by most recent decision date.
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| K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT | Jun 5, 1987 | Substantially Equivalent |
| K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE | Mar 31, 1987 | Substantially Equivalent |
| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | Mar 12, 1987 | Substantially Equivalent |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | Jul 20, 1984 | Substantially Equivalent |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | Jul 2, 1984 | Substantially Equivalent |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | Dec 30, 1983 | Substantially Equivalent |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | Oct 14, 1983 | Substantially Equivalent |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | May 9, 1983 | Substantially Equivalent |