Product code LJG
- Device name
- Quality Control Slides
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943228 | MICROSPORIDIUM CONTROL SET | Meridian Diagnostics, Inc. | 1994-10-27 |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1993-01-15 |
| K890718 | GRAM STAIN CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Scientific Device Laboratory, Inc. | 1989-03-16 |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | Bion Ent., Ltd. | 1989-02-17 |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 |
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 |
| K883568 | HISTO-CHECK ACID FAST SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 |
| K883208 | HISTO-CHECK SLIDES | Val Tech Diagnostics, Inc. | 1988-08-25 |
| K881106 | ACID FAST BACILLI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 |
| K881109 | SPIROCHETES HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 |
| K881112 | FUNGI HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-21 |
| K881110 | LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-12 |
| K881108 | PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-04-12 |
| K881111 | INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL | Sigma Diagnostics, Inc. | 1988-03-30 |
| K881107 | INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES | Sigma Diagnostics, Inc. | 1988-03-30 |
| K880962 | ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES | Alpha-Tec Systems, Inc. | 1988-03-30 |
| K840517 | PROTOZOA STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 |
| K840516 | METACHROMATIC GRANULE STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 |
| K840515 | ACID FAST BACILLI STAIN CONTROL | Scientific Device Laboratory, Inc. | 1984-03-09 |
| K830134 | Q-CHECK REAGENT STANDARDS | Lab Ability, Inc. | 1983-01-09 |
| K823706 | ATS AFB STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 |
| K823705 | ATS PARASITOLOGY STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 |
| K823704 | ATS GRAM STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 |
| K822604 | ACID FAST QUALITY CONTROL SLIDES | Medastat Scientific Corp. | 1982-09-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810047422020 | N/A | Scientific Device Laboratory, Inc. | 2024-01-09 |
| 00810047422013 | N/A | Scientific Device Laboratory, Inc. | 2024-01-09 |
| 00810047421245 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421238 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421221 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421214 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421207 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421191 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420774 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421252 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047421269 | N/A | Scientific Device Laboratory, Inc. | 2023-01-31 |
| 00810047420071 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420088 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420095 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420101 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420118 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420125 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420132 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420170 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420187 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420064 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00810047420057 | N/A | Scientific Device Laboratory, Inc. | 2023-01-30 |
| 00613647020432 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647020425 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00816085020297 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-07-21 |
| B502BSB57980 | Myogenin control slides | BIO SB, INC. | 2020-06-02 |
| B502BSB60350 | WT1 control slides | BIO SB, INC. | 2020-06-01 |
| B502BSB33620 | Inhibin alpha control slides | BIO SB, INC. | 2020-06-01 |
| B502BSB27320 | Cytokeratin 17 control slides | BIO SB, INC. | 2020-06-01 |
| B502BSB25930 | Spectrin control slides | BIO SB, INC. | 2020-06-01 |