510(k) K821597
- Device
- BRAIN HEART INFUSION
- Applicant
- HARDY MEDIA
- 510(k) number
- K821597
- Product code
- JSC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-08
- Date received
- 1982-05-20
- Regulation
- 866.2350
- Classification name
- Culture Media, General Nutrient Broth
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2016672
- 1119779
- 3005182159
- 3015715780
- 1111096
- 2022807
- 1924669
- 3005182157
- 2916932
- 8010096
- 1210083
- 3027341451
- 9680687
- 3009547954
- 9615754
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850143 | SPORDEX CULTURE MEDIA | American Sterilizer Co. | 1985-03-05 |
| K842852 | BRAIN HEART INFUSION BROTH | Anarobe Systems | 1984-08-03 |
| K842849 | TRYPTICASE SOY BROTH | Anarobe Systems | 1984-08-03 |
| K841221 | BRAIN HEART INFUSION BROTH | Anaerobe Systems | 1984-04-04 |
| K841219 | SHOPPED MEAT CARBOHYDRATE | Anaerobe Systems | 1984-04-04 |
| K833300 | SABOURAUD BHI AGAR | Acumedia Manufacturers, Inc. | 1983-11-07 |
| K832620 | TRYPTIC SOY BROTH MEDIA | Carroll Biological Corp. | 1983-09-12 |
| K832619 | THIOGLYCOLLATE MEDIUM | Carroll Biological Corp. | 1983-09-12 |
| K832570 | EXTRACT BROTH | Acumedia Manufacturers, Inc. | 1983-09-12 |
| K832569 | INFUSION BROTH | Acumedia Manufacturers, Inc. | 1983-09-12 |
| K830437 | CHS | Dms Laboratories | 1983-03-17 |
| K822487 | MINITEK GRAM-POSITIVE BROTH & SET AND | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-21 |
| K822665 | WILKINS-CHALGREN ANAEROBE BROTH | Oxoid U.S.A., Inc. | 1982-09-21 |
| K821864 | THIOGLYCOLLATE MED. W/VITAMIN K-1 | Granite Diagnostics, Inc. | 1982-07-13 |
| K821610 | THIOGLYCOLATE WITHOUT INDICATOR | Hardy Media | 1982-07-06 |
Legacy Summary#
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FDA Review#
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