510(k) K822197
- Device
- NEEDLE HOLDERS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822197
- Product code
- LCR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-16
- Date received
- 1982-07-23
- Regulation
- 862.3900
- Classification name
- Fluorescent Immunoassay, Tobramycin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003561301
- 3006198300
- 3010939897
- 3033967997
- 2050012
- 2050010
- 8020888
- 2517506
- 3005333358
- 2432235
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060998 | QMS TOBRAMYCIN | Seradyn, Inc. | 2006-07-21 |
| K974029 | ACS TOBRAMYCIN | Chiron Diagnostics Corp. | 1998-02-12 |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K952568 | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | Beckman Instruments, Inc. | 1995-08-08 |
| K911940 | OPUS(R) TOBRAMYCIN | Pb Diagnostic Systems, Inc. | 1991-07-01 |
| K911613 | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | Exmoor Plastics , Ltd. | 1991-06-28 |
| K854873 | INTRAOCULAR PRESSURE REDUCER | Mira, Inc. | 1986-02-04 |
| K850058 | DU PONT TOBRAMYCIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 |
| K832408 | STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM | American Dade | 1983-08-26 |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
| K820130 | ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY | Syva Co. | 1982-02-05 |
| K813542 | TOBRAMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 |
| K810941 | AMES TDA TOBRAMYCIN TEST | Miles Laboratories, Inc. | 1981-04-17 |
| K802668 | CYBREX TOBRAMYCIN | Abbott Laboratories | 1980-11-24 |
Legacy Summary#
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FDA Review#
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