510(k) K851591
- Device
- PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD
- Applicant
- PREFERRED MICRO-MEDIA
- 510(k) number
- K851591
- Product code
- JSJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-13
- Date received
- 1985-04-16
- Regulation
- 866.2360
- Classification name
- Culture Media, Selective And Non-differential
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT SCOTT
- Address
- 5223 Telegraph Rd. Toledo OH US 43612 43612
FDA Registration Numbers#
- 1125797
- 1119779
- 8010096
- 1210083
- 3017717188
- 2025606
- 2951280
- 3017871324
- 3015715780
- 3005182157
- 3016741564
- 1216735
- 1924669
- 1645368
- 1111096
- 2022807
- 3012162776
- 3002444944
- 3005182159
- 1530248
- 9610649
- 2916932
- 3038136284
- 3009547954
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Lakewood Biochemical Co., Inc. | 1988-06-22 |
| K881578 | STREPTOSEL | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881574 | W-L DIFFERENTIAL MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881573 | PHYTONE YEAST EXTRACT AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881571 | YM BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881570 | SABOURAUD MALTOSE AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881565 | INHIBITORY MOLD AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881561 | TERGITOL 7 BROTH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881549 | MYCOLOGICAL AGAR W/LOW PH | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881547 | MITIS SALIVARIUS AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881544 | LITTMAN AGAR | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881530 | BRILLIANT GREEN AGAR W/SULFADIAZINE | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881526 | CHAPMAN STONE MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K881524 | DERMATOPHYTE TEST MEDIUM | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K880123 | LOWENSTEIN-JENSEN SLANT | Hardy Media | 1988-03-31 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases