FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELISA SYSTME
K Number: K781269
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
16
Review Days
133
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
- ELISA SYSTME
- K Number
- K781269
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gilford Instrument Laboratories, Inc.
- Date Received
- July 24, 1978
- Decision Date
- December 4, 1978
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJQ), ordered by most recent decision date.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIGENE DML 2000 MICROPLATE LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STAT TRACKS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANTHOS PHACTS VERSION MICROPLATE READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CBI 7520 READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Gilford Instrument Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Nov 29, 1982 | Substantially Equivalent |
| K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER | Jun 24, 1982 | Substantially Equivalent |
| K802609 | CHEMISTRY ANALYZER IMPACT 400 | Nov 26, 1980 | Substantially Equivalent |
| K801889 | MODEL 203S CLINICAL CHEMISTRY ANALYZER | Sep 26, 1980 | Substantially Equivalent |
| K800085 | SYSTEM 203 CHEMISTRY ANALYZER | Feb 13, 1980 | Substantially Equivalent |
| K792361 | SYSTEM 103 CHEMISTRY ANALYZER | Dec 27, 1979 | Substantially Equivalent |
| K792087 | MICROFLAME PHOTOMETER | Nov 13, 1979 | Substantially Equivalent |
| K791968 | EIA (ELISA) READER | Oct 17, 1979 | Substantially Equivalent |
| K790072 | ANALYZER, IMPACT 200 | Feb 22, 1979 | Substantially Equivalent |
| K790073 | ANALYZER, IMPACT 100 | Feb 22, 1979 | Substantially Equivalent |