510(k) K843610
- Device
- PERSPECTIVE CHEMICAL ANALYZER
- Applicant
- American Monitor Corp.
- 510(k) number
- K843610
- Product code
- JJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-05
- Date received
- 1984-09-13
- Regulation
- 862.2160
- Classification name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3012057020
- 9612296
- 3007500635
- 3002889627
- 2030861
- 3009238284
- 3006198300
- 3013660430
- 3002806944
- 9610240
- 9615056
- 3010825766
- 8020888
- 1219029
- 3042177088
- 3004438098
- 9610806
- 3016244760
- 3037000637
- 3027977508
- 3005509212
- 3004378326
- 1000455123
- 2431530
- 3034707949
- 1717966
- 3030234142
- 3007603826
- 1643621
- 3014325803
- 3003917514
- 3004145393
- 3005529799
- 3003542872
- 1317202
- 2050010
- 3020978007
- 3004434309
- 8030478
- 3010610113
- 9614698
- 3006716639
- 3014353045
- 3007111389
- 3016438761
- 1319436
- 3000308930
- 2027969
- 3007361513
- 3023162659
- 3021394862
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 3010421384
- 3014717638
- 3003795116
- 1217183
- 3003637681
- 3007118747
- 2032900
- 3004102403
- 1832216
- 3014840402
- 3033967997
- 9610942
- 3004529019
- 3010031137
- 3030493719
- 1424235
- 3042268054
- 3005748564
- 3012526002
- 1931251
- 2182595
- 3042244350
- 3007135420
- 2432235
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
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