FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIA KIT, GLUCOSE
K Number: K782143
·
Decision Feb 22, 1979
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
10
Review Days
57
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Basic Information
- Device Name
- RIA KIT, GLUCOSE
- K Number
- K782143
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1335
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Laboratories, Inc.
- Date Received
- December 27, 1978
- Decision Date
- February 22, 1979
- Product Code
- JME
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JME | Radioimmunoassay, Glucagon | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JME), ordered by most recent decision date.
DOUBLE ANTIBODY GLUCAGON
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GLUCAGON RIA MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Serono Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Mar 2, 1984 | Substantially Equivalent |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Mar 31, 1981 | Substantially Equivalent |
| K810625 | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- | Mar 27, 1981 | Substantially Equivalent |
| K792043 | PAP-CHECK RIA KIT | Oct 30, 1979 | Substantially Equivalent |
| K790679 | ESTRADIOL RIA KIT | May 23, 1979 | Substantially Equivalent |
| K790440 | PROGESTERONE | May 3, 1979 | Substantially Equivalent |
| K782103 | RIA KIT, NEONATAL T4 | Jan 17, 1979 | Substantially Equivalent |
| K781733 | RIA KIT, PREG-STAT | Dec 20, 1978 | Substantially Equivalent |
| K781285 | INSULIN RIA KIT | Aug 14, 1978 | Substantially Equivalent |