FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN ELECTROPHORESIS CONTROL
K Number: K810919
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
44
Review Days
17
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Basic Information
- Device Name
- HEMOGLOBIN ELECTROPHORESIS CONTROL
- K Number
- K810919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7440
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Isolab, Inc.
- Date Received
- April 6, 1981
- Decision Date
- April 23, 1981
- Product Code
- JBD
- 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 |
|---|---|---|---|
| JBD | System, Analysis, Electrophoretic Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBD), ordered by most recent decision date.
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
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INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
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ACID HEMOGLOBIN KIT
FDA 510(k)
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HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
FDA 510(k)
FDA Class 2
·Hematology
SPIFE ALKALINE HEMOGLOBIN
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REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Isolab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951014 | ISOLAB'S T4 TEST KIT | Oct 18, 1996 | Substantially Equivalent |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Feb 1, 1996 | Substantially Equivalent |
| K943547 | PHENYLALANINE TEST KIT | Jan 26, 1996 | Substantially Equivalent |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | Sep 21, 1995 | Substantially Equivalent |
| K950415 | FLUOROSCAN NEONATAL | Sep 5, 1995 | Substantially Equivalent |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | Jan 20, 1995 | Substantially Equivalent |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Jan 20, 1995 | Substantially Equivalent |
| K944185 | ISOSCAN | Nov 17, 1994 | Substantially Equivalent |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Apr 26, 1994 | Substantially Equivalent |
| K923153 | HEMOCARD, HEMOGLOBIN C ASSAY | Jan 27, 1994 | Substantially Equivalent |