510(k) K882636
- Device
- ALN DISCS
- Applicant
- CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
- 510(k) number
- K882636
- Product code
- JTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-16
- Date received
- 1988-06-27
- Regulation
- 866.2660
- Classification name
- Discs, Strips And Reagents, Microorganism Differentiation
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LESLIE SCARBOROUGH
- Address
- P.O. Box 1328 Stone Mountain GA US 30086 30086
FDA Registration Numbers#
- 3013490757
- 1119779
- 8010096
- 1210083
- 3023191945
- 3006897996
- 9615754
- 3006091463
- 8010383
- 3016741564
- 1924669
- 2016672
- 9615755
- 2022807
- 3009307598
- 3024171133
- 9610649
- 3013160357
- 3006440892
- 2242239
- 8020667
- 3043126851
- 3009171251
- 2916932
- 2647876
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050352 | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | Ameritek Research, LLC | 2005-09-01 |
| K970832 | PYR SWAB | Remel, Inc. | 1997-04-24 |
| K970834 | GRAM SWAB | Remel, Inc. | 1997-04-17 |
| K970833 | INDOLE SWAB | Remel, Inc. | 1997-04-02 |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | Microbiologics, Inc. | 1997-02-06 |
| K962966 | IDS RAPID CB PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| K961191 | COLISCREEN | Hardy Diagnostics | 1996-06-17 |
| K960996 | M. CAT BUTYRATE DISK | Hardy Diagnostics | 1996-04-18 |
| K955826 | GIBSON ID-M. CAT. | Gibson Laboratories, Inc. | 1996-02-29 |
| K954783 | DRYSLIDE CARTARRHALIS | Difco Laboratories, Inc. | 1996-02-06 |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | Microbiologics, Inc. | 1995-12-20 |
| K953247 | GIBSON ID A.E. TEST | Gibson Laboratories, Inc. | 1995-11-20 |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | Microbiologics, Inc. | 1995-08-24 |
| K950346 | B-L RED(TM) DISCS | Oxis Intl., Inc. | 1995-05-05 |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | Microbiologics, Inc. | 1995-04-24 |
Legacy Summary#
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FDA Review#
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