510(k) K790073
- Device
- ANALYZER, IMPACT 100
- Applicant
- GILFORD INSTRUMENT LABORATORIES, INC.
- 510(k) number
- K790073
- Product code
- JJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-22
- Date received
- 1979-01-11
- Regulation
- 862.2500
- Classification name
- Analyzer, Enzyme, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3008517993
- 3009238284
- 1550101
- 3030234142
- 3010402964
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972024 | CODA AUTOMATED EIA ANALYZER | Bio-Rad | 1997-07-30 |
| K944731 | ABBOTT IMX 2 ANALYZER | Abbott Laboratories | 1994-12-19 |
| K931970 | ABBOTT IMX2 ANALYER | Abbott Laboratories | 1993-06-16 |
| K930898 | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | Bio-Rad | 1993-04-21 |
| K780972 | QUICKRATE REACTION RATE ANALYZER | Olympus Corp. | 1978-08-14 |
| K771591 | MINISTAT-S CHEMISTRY ANALYZER | Biokinetix Corp. | 1977-09-20 |
| K770401 | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Legacy Summary#
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FDA Review#
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