510(k) K831641
- Device
- Reader Microelisa System
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K831641
- Product code
- LIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-11
- Date received
- 1983-05-23
- Regulation
- 866.2660
- Classification name
- Device, General Purpose, Microbiology, Diagnostic
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- 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#
- 3009756327
- 1119779
- 2024311
- 3011947913
- 8010096
- 3005360469
- 3010278338
- 2029275
- 3007583567
- 3005735987
- 3013046485
- 3010220595
- 3034669683
- 2919016
- 3005720829
- 3030516433
- 3009974297
- 3003750284
- 3024463179
- 2244900
- 2023365
- 3019387954
- 1924669
- 3014642322
- 3010141591
- 1528695
- 3003895930
- 3020440077
- 3032847781
- 2022807
- 3008850249
- 1221359
- 3012259842
- 9610649
- 3042585783
- 2016673
- 3007135420
- 3023809973
- 3042159574
- 3006440892
- 3030178466
- 3011527950
- 2029372
- 3005273623
- 3003718445
- 2150138
- 1423625
- 3003703247
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | Osmetech | 2003-01-29 |
| K920416 | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | Behring Diagnostics, Inc. | 1992-04-08 |
| K912558 | GULL ELISAWARE | Gull Laboratories, Inc. | 1991-09-16 |
| K872273 | CORNING EASY WASH ELISA PLATES | Corning Medical & Scientific | 1987-07-07 |
| K871559 | CELL LIFTER | Corning Costar Corp. | 1987-05-15 |
| K864249 | NORMAL SALINE STERILE | Mds Laboratories, Inc. | 1987-03-31 |
| K863789 | CORNING ELISA PLATES | Corning Medical & Scientific | 1986-10-03 |
| K862112 | MICROSCOPE SLIDES | Abco Dealers, Inc. | 1986-06-13 |
| K854604 | AUTO MASH | Dynatech Corp. | 1985-12-06 |
| K854603 | MULTI MASH 2000 | Dynatech Corp. | 1985-12-06 |
| K854602 | MINI MASH 2000 | Dynatech Corp. | 1985-12-06 |
| K854423 | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | Dynatech Laboratories, Inc. | 1985-11-20 |
| K853285 | MYWASHER 5 | Scientific Sales Intl., Inc. | 1985-10-04 |
| K853745 | MIC-CONCEPT VIEWBOX | Microtech Medical Systems, Inc. | 1985-09-19 |
| K850725 | QUADRA TITER MICRO PLATES | Microtech Medical Systems, Inc. | 1985-04-30 |