FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOTOLOGY PRODU&TS (5 IN ALL)
K Number: K770803
·
Decision Jul 5, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
22
Review Days
64
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
- HEMOTOLOGY PRODU&TS (5 IN ALL)
- K Number
- K770803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- May 2, 1977
- Decision Date
- July 5, 1977
- Product Code
- GKK
- 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 |
|---|---|---|---|
| GKK | Cyanomethemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKK), ordered by most recent decision date.
RAICHEM TM HEMOGLOBIN REAGENT
FDA 510(k)
FDA Class 2
·Hematology
MODIFIED HEMOGLOBIN REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
KVM PREPACK HEMATOLOGY REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
HEMOGLOBIN REAGENT SET
FDA 510(k)
FDA Class 2
·Hematology
CYMET-PLUS
FDA 510(k)
FDA Class 2
·Hematology
UNIPAK HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Hycel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |