Panels › Hematology › Product code JTS · Class 1
Stains, Microbiologic
Regulation 864.1850
0510(k)s in 12 months (40 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in JTS
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel Co. | 12 | 1 |
| Becton Dickinson & Co. | 0 | 7 |
| Alpha-Tec Systems, Inc. | 5 | 0 |
| Accra Laboratories, Inc. | 4 | 0 |
| Scientific Device Laboratory, Inc. | 3 | 0 |
| Marion Laboratories, Inc. | 2 | 0 |
| Alpha-Tech Systems, Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| BioMerieux SA | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 1996 | K960095 | BACTIDROP CALCOFLUOR WHITE Remel Co. | JTS |
| Mar 19, 1996 | K960090 | CALCOFLUOR WHITE STAIN KIT Remel Co. | JTS |
| Jun 9, 1992 | K920976 | BACTIDROP INDIA INK Remel Co. | JTS |
| Jun 9, 1992 | K920975 | BACTIDROP CALCOFLUOR WHITE Remel Co. | JTS |
| Jun 9, 1992 | K920970 | BACTIDROP KOH (10%) Remel Co. | JTS |
| Jun 13, 1989 | K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 Intl. Remote Imaging Systems | JTS |
| Mar 23, 1989 | K890861 | ATS DOBELL & O'CONNOR'S IODINE Alpha-Tec Systems, Inc. | JTS |
| Feb 24, 1989 | K890020 | ATS LUGOL'S IODINE SOLUTION Alpha-Tec Systems, Inc. | JTS |
| Oct 25, 1988 | K884069 | SNAP N' STAIN IODINE STAIN Scientific Device Laboratory, Inc. | JTS |
| Aug 30, 1988 | K883052 | METHENO-STAIN KIT Scientific Device Laboratory, Inc. | JTS |
| Aug 17, 1988 | K883061 | ATS PARA-SET CARBOL-XYLENE SOLUTION Alpha-Tech Systems, Inc. | JTS |
| Aug 17, 1988 | K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION Alpha-Tec Systems, Inc. | JTS |
| May 13, 1988 | K880989 | ATS CRYPTOSPORIDIUM STAIN SET Alpha-Tec Systems, Inc. | JTS |
| May 4, 1988 | K881598 | SDL TRICHROME STAIN Scientific Device Laboratory, Inc. | JTS |
| Apr 18, 1988 | K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY Wescor, Inc. | JTS |
| Mar 30, 1988 | K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) Alpha-Tec Systems, Inc. | JTS |
| Mar 25, 1988 | K880718 | CALCOFLUOR WHITE STAIN KIT Remel Co. | JTS |
| Nov 25, 1987 | K874662 | MYCO-FLUOR REAGENT A & B Scott Laboratories, Inc. | JTS |
| Oct 6, 1987 | K873413 | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR Lakewood Biochemical Co., Inc. | JTS |
| Jul 29, 1987 | K872189 | METHANOL, ABSOLUTE Remel Co. | JTS |
| Jul 29, 1987 | K872187 | TB KINYOUN CARBOLFUCHSIN Remel Co. | JTS |
| Jul 29, 1987 | K872186 | SULFURIC ACID 10% Remel Co. | JTS |
| Jul 29, 1987 | K872185 | LIGHT GREEN Remel Co. | JTS |
| Jul 29, 1987 | K872184 | TB METHYLENE BLUE Remel Co. | JTS |
| May 15, 1987 | K871606 | SPOTTEST FLAGELLA STAIN Difco Laboratories, Inc. | JTS |
| Apr 29, 1987 | K871532 | TOMTEC GRAM STAINER CRYSTAL VIOLET Remel Co. | JTS |
| Mar 30, 1987 | K870988 | PRICE'S ACID-FAST STAIN Devetec, Inc. | JTS |
| Oct 22, 1985 | K853896 | GRAM STAIN KIT Sigma Diagnostics, Inc. | JTS |
| Apr 29, 1985 | K851494 | TWO-STEP ACID FAST BACTERIA STAIN Accra Laboratories, Inc. | JTS |
| Apr 29, 1985 | K851493 | KINYOUN ACID FAST STAIN KIT Accra Laboratories, Inc. | JTS |
| Sep 14, 1984 | K843429 | GRAM STAIN SET W/STABILIZED IODINE Accra Laboratories, Inc. | JTS |
| Sep 11, 1984 | K843050 | GRAM STAIN Reagent Laboratory, Inc. | JTS |
| Jun 8, 1983 | K831060 | TRICHROME STAIN American Micro Scan | JTS |
| May 27, 1982 | K821038 | FAST VIOLET B Dms Laboratories | JTS |
| Dec 22, 1981 | K813369 | GRAM STAIN REAGENTS AND KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | JTS |
| Sep 29, 1981 | K812668 | AFB STAIN SET Carr-Scarborough Microbiologicals, Inc. | JTS |
| Jul 27, 1981 | K811780 | ACCRA-LAB GRAM STAIN SET 55760 Accra Laboratories, Inc. | JTS |
| Oct 3, 1978 | K781643 | ACID FAST KIT Bioscientific | JTS |
| Aug 14, 1978 | K781061 | DROPPERS, SOLUTION, IODINE Marion Laboratories, Inc. | JTS |
| Mar 22, 1978 | K780346 | MIF PROCEDURE KIT Marion Laboratories, Inc. | JTS |
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