510(k) K872193
- Device
- FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K872193
- Product code
- KZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-22
- Date received
- 1987-06-08
- Regulation
- 866.2330
- Classification name
- Culture Media, Enriched
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 1125797
- 1111096
- 1119779
- 2022807
- 3015715780
- 3012162776
- 3015492990
- 1210083
- 3005182159
- 2916932
- 1530248
- 1216735
- 3005182157
- 3016741564
- 3038136284
- 3009547954
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) | Oxoid U.S.A., Inc. | 1988-10-25 |
| K881995 | DIAMOND'S MEDIUM MODIFIED | Remel Co. | 1988-06-02 |
| K880134 | MIDDLEBROOK 7H11 AGAR | Hardy Media | 1988-03-31 |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | Hardy Media | 1988-03-31 |
| K880122 | MIDDLEBROOK 7H9 BROTH | Hardy Media | 1988-03-31 |
| K880138 | WALLENSTEIN MEDIUM SLANT | Hardy Media | 1988-03-30 |
| K880109 | CYSTINE TRYPTIC MEDIUM BASE | Hardy Media | 1988-03-30 |
| K880127 | POTATO DEXTROSE AGAR | Hardy Media | 1988-03-07 |
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | Otisville Biopharm, Inc. | 1988-01-28 |
| K874177 | BIOTIS (TM) BCYE | Otisville Biopharm, Inc. | 1987-12-04 |
| K873267 | ECG BASED MEDIA | Central Media | 1987-11-04 |
| K873266 | MIDDLEBROOK BASED MEDIA | Central Media | 1987-10-28 |
| K873952 | MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 | Lakewood Biochemical Co., Inc. | 1987-10-23 |
| K873321 | SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 | Lakewood Biochemical Co., Inc. | 1987-09-29 |
| K873320 | SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD | Lakewood Biochemical Co., Inc. | 1987-09-29 |
Legacy Summary#
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FDA Review#
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